Valvular insufficiency repair device and method

ABSTRACT

This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In a representative embodiment, a support frame configured to be implanted in a heart valve comprises a main body formed by formed by a plurality of inner members forming an inner clover and a plurality of outer members forming an outer clover. The support frame can include gaps located between inner members of the plurality of inner members and outer members of the plurality of outer members. The inner clover can be radially inside the outer clover, and the outer clover can have larger dimensions than the inner clover. The support frames herein can be radially expandable and collapsible.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/181,858, filed Nov. 6, 2018, which is a continuation of U.S. patentapplication Ser. No. 15/482,555, filed Apr. 7, 2017, granted as U.S.Pat. No. 10,507,106, which is a divisional of U.S. patent applicationSer. No. 14/549,431, filed Nov. 20, 2014, granted as U.S. Pat. No.9,622,863, which claims priority to and the benefit of U.S. ProvisionalPatent Application No. 61/907,650, filed Nov. 22, 2013, all of which areincorporated herein by reference in their entirety.

FIELD

This application relates to methods, systems, and apparatus for safelyreplacing native heart valves with prosthetic heart valves.

BACKGROUND

Prosthetic heart valves have been used for many years to treat cardiacvalvular disorders. The native heart valves (such as the aortic,pulmonary, tricuspid and mitral valves) serve critical functions inassuring the forward flow of an adequate supply of blood through thecardiovascular system. These heart valves can be rendered less effectiveby congenital, inflammatory, or infectious conditions. Such conditionscan eventually lead to serious cardiovascular compromise or death. Formany years the definitive treatment for such disorders was the surgicalrepair or replacement of the valve during open heart surgery.

More recently a transvascular technique has been developed forintroducing and implanting a prosthetic heart valve using a flexiblecatheter in a manner that is less invasive than open heart surgery. Inthis technique, a prosthetic valve is mounted in a crimped state on theend portion of a flexible catheter and advanced through a blood vesselof the patient until the valve reaches the implantation site. The valveat the catheter tip is then expanded to its functional size at the siteof the defective native valve, such as by inflating a balloon on whichthe valve is mounted. Alternatively, the valve can have a resilient,self-expanding stent or frame that expands the valve to its functionalsize when it is advanced from a delivery sheath at the distal end of thecatheter.

Balloon-expandable valves are commonly used for treating heart valvestenosis, a condition in which the leaflets of a valve (e.g., an aorticvalve) become hardened with calcium. The hardened leaflets provide agood support structure on which the valve can be anchored within thevalve annulus. Further, the catheter balloon can apply sufficientexpanding force to anchor the frame of the prosthetic valve to thesurrounding calcified tissue. There are several heart conditions,however, that do not involve hardened valve leaflets but which are stilldesirably treated by valve replacement. For example, aorticinsufficiency (or aortic regurgitation) occurs when an aortic valve doesnot close properly, allowing blood to flow back into the left ventricle.One cause for aortic insufficiency is a dilated aortic annulus, whichprevents the aortic valve from closing tightly. In such cases, theleaflets are usually too soft to provide sufficient support for aballoon-expandable prosthetic valve. Additionally, the diameter of theaortic annulus may continue to vary over time, making it dangerous toinstall a prosthetic valve that is not reliably secured in the valveannulus. Mitral insufficiency (or mitral regurgitation) involves thesesame conditions but affects the mitral valve.

Self-expanding prosthetic valves are sometimes used for replacingdefective native valves with non-calcified leaflets. Self-expandingprosthetic valves, however, suffer from a number of significantdrawbacks. For example, once a self-expanding prosthetic valve is placedwithin the patient's defective heart valve (e.g., the aorta or mitralvalve), it continues to exert an outward force on the valve annulus.This continuous outward pressure can cause the valve annulus to dilatefurther, exacerbating the condition the valve was intended to treat.Additionally, when implanting a self-expanding valve, the outwardbiasing force of the valve's frame tends to cause the valve to beejected very quickly from the distal end of a delivery sheath.

The size of the prosthetic valve to be implanted into a patient can alsobe problematic when treating aortic or mitral insufficiency.Specifically, the size of a prosthetic valve used to treat aortic ormitral insufficiency is typically larger than a prosthetic valve used totreat aortic or mitral stenosis. This larger valve size makes thedelivery procedure much more difficult.

Additionally, many prosthetic heart valves are retained by a stent orframe (i.e., a “pinch”) placed in the aortic annulus prior toimplantation of the valve, with the valve being configured to pinch thenative valve leaflets against the frame. However, such frames typicallyrequire attachment to the delivery apparatus to hold the frame in placebefore and/or during implantation of the prosthetic heart valve. Thisrequires that the frame delivery apparatus remain in the patient duringimplantation of the prosthetic heart valve, which can complicateimplantation of the valve.

Accordingly, there exists a need for improved methods, systems, andapparatus for delivering expandable prosthetic heart valves (e.g.,balloon-expandable prosthetic valves). Embodiments of the methods,systems, and apparatus desirably can be used to replace native heartvalves that do not have calcified leaflets (e.g., aortic valvessuffering from aortic insufficiency). Furthermore, embodiments of themethods, systems, and apparatus desirably enable precise and controlleddelivery of the prosthetic valves.

SUMMARY

An aortic insufficiency repair device improves aortic valve function byreducing a diameter of the aortic valve annulus, either an actualdiameter and/or effective diameter. Embodiments of the device comprise apercutaneous or minimally invasively implantable ring-shaped or annularsupport structure that is deployable and anchorable on the downstreamside of the aortic valve. Some embodiments of the device clip onto thenative leaflets of the aortic valve at or near the commissures, therebyreducing the effective diameter of the valve annulus. Some embodimentsof the device are secured in an over-expanded state and reduce theactual diameter of the aortic valve when the device springs back towardsits default size.

Also disclosed below are representative embodiments of methods, systems,and apparatus used to replace deficient native heart valves withprosthetic heart valves. Embodiments of the disclosed methods, systems,and apparatus can be used, for example, to replace an aortic valvesuffering from aortic insufficiency or a mitral valve suffering frommitral insufficiency. These embodiments are not limiting, however, asthe disclosed methods, systems, and apparatus can be more generallyapplied to replace any heart valve.

In another representative embodiment a support frame configured to beimplanted in a heart valve comprises an annular main body formed by aplurality of angled struts, the main body including a plurality of peaksformed by the intersection of respective adjacent struts. The supportframe further comprises one or more leaflet-engaging mechanisms locatedbeneath respective peaks of the support frame. Each of the one or moreleaflet-engaging mechanisms defines a leaflet-receiving space betweentwo opposing surfaces for engaging portions of adjacent leafletstherebetween, wherein the leaflet-receiving space can be adjustable tofacilitate placement of the portions of the adjacent leaflets within theleaflet-engaging mechanism. The support frame can be radially expandableand collapsible.

In particular embodiments, the one or more leaflet-engaging mechanismscan comprise one or more pairs of leaflet clipping arms located beneathrespective peaks of the support frame, wherein each clipping armcomprises a fixed end portion and a free end portion, the free endportions of each pair being configured to engage portions of adjacentleaflets therebetween. In some embodiments, the fixed end portion ofeach leaflet clipping arm is connected to a respective strut at alocation below a respective peak and the leaflet clipping arm extendsfrom the fixed end portion to the free end portion in a direction towardthe peak. In other embodiments, the fixed end portion of each leafletclipping arm is connected to a respective strut at a location below arespective peak and the leaflet clipping arm extends from the fixed endportion to the free end portion in a direction away from the peak.

In some embodiments, the free end portions of each pair of leafletclipping arms can be curved or bent away from each other.

In some embodiments, the one or more leaflet-engaging mechanisms can bemovable between an open position and a closed position. In someembodiments, the support frame is configured such that when the supportframe is partially deployed from a delivery catheter the one or moreleaflet-engaging mechanisms are in the open position. In someembodiments, the support frame is configured such that when the supportframe is fully deployed from the delivery catheter the one or moreleaflet-engaging mechanisms move to the closed position.

In some embodiments, the support frame further comprises one or moreleaflet-engaging subunits.

In some embodiments, the one or more leaflet-engaging mechanisms areconfigured to be positioned over one or more commissures formed by theleaflets of the heart valve. In some embodiments, the one or moreleaflet-engaging mechanisms comprise three leaflet-engaging mechanismsconfigured to engage the commissures of the aortic valve.

In some embodiments, the support frame further comprises one or moreretaining arms coupled to the one or more of the peaks, the one or moreretaining arms being configured to engage a delivery device.

In some embodiments, the support frame is configured to reduce theorifice area of the heart valve after implantation.

In another representative embodiment, a method of treating valvularinsufficiency comprises inserting a delivery catheter into thevasculature of a heart proximate a heart valve, the delivery cathetercarrying a support frame in a radially collapsed state. The method canfurther comprise positioning the delivery catheter such that one or moreleaflet-engaging mechanisms of the support frame are aligned withcommissures of the heart valve. Each of the one or more leaflet-engagingmechanisms is located below a respective apex of the support frame anddefines a leaflet-receiving space between two opposing surfaces, whereinthe leaflet-receiving space is adjustable. The method further comprisesat least partially deploying the support frame from the deliverycatheter to allow the support frame to radially expand to at least apartially deployed state, and engaging one or more of the commissures ofthe heart valve with the one or more leaflet-engaging mechanisms.

In some embodiments, the act of at least partially deploying the supportframe causes the one or more leaflet-engaging mechanisms to move to openposition to increase the leaflet-receiving space.

In some embodiments, the method further comprises fully deploying thesupport frame from the delivery catheter such that the one or moreleaflet-engaging mechanisms move from the open position to a closedposition.

In some embodiments, engaging one or more of the commissures of theheart valve with the one or more leaflet-engaging mechanisms iseffective to reduce the orifice area of the heart valve.

In some embodiments, the method further comprises releasing the supportframe from the delivery catheter and allowing the leaflets to regulatethe flow of blood through the heart valve.

In some embodiments, the method further comprises, after releasing thesupport frame from the delivery catheter and allowing the leaflets toregulate the flow of blood through the heart valve, deploying aprosthetic heart valve within the leaflets such that the leaflets arecaptured between the support frame and the prosthetic heart valve.

In some embodiments, the act of engaging comprises actuating one or moreleaflet-engaging mechanisms from an open position to a closed positionsuch that the leaflet-engaging mechanisms engage the commissures of theheart valve.

In another representative embodiment, a support frame configured to beimplanted in a heart valve comprises an annular main body formed by aplurality of angled struts, the main body including a plurality of peaksformed by the intersection of respective adjacent struts. In lieu of orin addition to one or more leaflet-engaging mechanisms, the supportframe can have one or more frame-retaining mechanisms configured torestrain movement of the support frame in the heart by engaging one ormore portions of the aortic root and/or the aorta. The support frame canbe radially expandable and collapsible.

The foregoing and other objects, features, and advantages of theinvention will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary embodiment of a supportstructure according to the disclosed technology.

FIG. 2 is a cross-sectional view of a native aortic valve with thesupport structure of FIG. 1 positioned therein.

FIGS. 3 and 4 are perspective views of an exemplary delivery system forthe support structure of FIG. 1. In particular, FIG. 3 shows thedelivery system before the support structure is deployed, and FIG. 4shows the delivery system after the support structure is deployed.

FIG. 5 is an exploded view of the components of the exemplary deliverysystem shown in FIGS. 3 and 4.

FIG. 6 is a zoomed-in perspective view showing the mechanism forreleasably connecting the support structure to the exemplary deliverysystem of FIGS. 3 and 4.

FIGS. 7 and 8 are cross-sectional views of a patient's heartillustrating how the delivery system of FIGS. 3 and 4 can operate todeploy the support structure of FIG. 1 to a desired position on thepatient's aortic valve.

FIGS. 9-13 are cross-sectional views of a patient's heart illustratinghow an exemplary transcatheter heart valve (“THV”) can be deployed tothe patient's aortic valve and frictionally secured to the nativeleaflets using the support structure of FIG. 1.

FIG. 14 is a perspective view of another exemplary embodiment of asupport structure according to the disclosed technology.

FIG. 15 is a top view of the support structure embodiment shown in FIG.14

FIG. 16 is a side view of the support structure embodiment shown in FIG.14.

FIG. 17 is a cross-sectional view of a patient's heart illustrating howa delivery system can operate to deploy the support structure of FIG. 14to a desired position on the patient's aortic valve.

FIG. 18 is a cross-sectional view of a patient's heart illustrating howan exemplary THV can be deployed through the aortic arch and into thepatient's aortic valve, where it can be frictionally secured to thenative leaflets using the support structure of FIG. 14.

FIG. 19 is a cross-sectional view of a patient's heart showing a medicaldevice of another embodiment of the present invention including a stentthat supports a deflector for treating vessel aneurysms.

FIG. 20 is a plan view of a portion of a scaffold of the stent of FIG.19.

FIG. 21 is a cross-sectional view of a patient's heart showing a medicaldevice of another embodiment wherein a stent is covered with a deflectorand is tapered.

FIG. 22 is a cross-sectional view of a patient's heart showing a medicaldevice of another embodiment wherein a stent is covered with a balloonconfigured to fill an aneurysm in the insufficient vessel.

FIG. 23 is a cross-sectional view of a medical device of anotherembodiment wherein a stent is covered with a foam sleeve deflector.

FIG. 24 is a cross-sectional view of a patient's heart showing a medicaldevice of another embodiment including a deflector with an annulusshape.

FIG. 25 is a cross-sectional view of a patient's heart showing a medicaldevice of another embodiment including a pair of annulus shapeddeflectors.

FIG. 26 is a cross-sectional view of a patient's heart showing a medicaldevice of another embodiment including a deflector with a seal allowingpassage of THV delivery device.

FIG. 27 is cross-sectional view of a patient's heart showing a medicaldevice of another embodiment including a deflector with a resilienthourglass shape configured to resiliently aid in the pumping of blood.

FIG. 28 is a cross-sectional view of a patient's heart showing a medicaldevice of another embodiment including anchors on a foam deflectorsupported by a stent.

FIG. 29 is a perspective view of another embodiment of a support frame.

FIG. 30 is a cross-sectional perspective view of the support frame ofFIG. 29 implanted in a native heart valve.

FIG. 31 is a cross-sectional view of the support frame of FIG. 29implanted in a partial cross-section of the aorta.

FIG. 32 is another cross-sectional view of the support frame of FIG. 29implanted in a partial cross-section of the aorta.

FIG. 33 is a perspective view of another embodiment of a support frameincluding one or more pairs of leaflet-engaging members.

FIG. 34 is a perspective view of the support frame of FIG. 33 implantedin a partial section of an aorta.

FIG. 35 is a partial side elevation view of another embodiment of thesupport frame of FIG. 33 in which free end portions of theleaflet-engaging members are spherical.

FIG. 36 is a partial side elevation view of another embodiment of thesupport frame of FIG. 33 in which free end portions of theleaflet-engaging members are curved.

FIG. 37 is a partial side elevation view of the support frame of FIG. 36illustrating native leaflets engaged between the leaflet-engagingmembers.

FIG. 38 is a partial side elevation view of another embodiment of thesupport frame of FIG. 33 having a single leaflet-engaging member.

FIG. 39 is a partial side elevation view of another embodiment of thesupport frame of FIG. 33 having leaflet-engagement members extendingfrom distal apices of the support frame.

FIG. 40 is a side elevation view of another embodiment of a supportframe in a flattened state including pairs of leaflet-engaging membershaving curved sections.

FIG. 41 is a side elevation view of another embodiment of a supportframe in a flattened state including pairs of semi-annularleaflet-engaging members.

FIG. 42 is a plan view of the support frame of FIG. 41 implanted in theaortic root.

FIG. 43 is a partial side elevation view of another embodiment of asupport frame including a plurality of clipping members.

FIG. 44 is a side elevation view of a clipping arm of the support frameof FIG. 43

FIG. 45 is a partial side elevation view of the clipping members of thesupport frame of FIG. 43 illustrating the clipping members engagingleaflets of a native valve.

FIG. 46 is a side elevation view of a portion of a clipping member ofFIG. 43 illustrating forces applied to the clipping member.

FIG. 47 is a partial side elevation view another embodiment of a supportframe including one or more commissure clips.

FIG. 48 is a partial side elevation view of another embodiment of asupport frame including one or more pairs of curved leaflet-engagingmembers.

FIG. 49 is a partial side elevation view of another embodiment of thesupport frame of FIG. 48 including one or more pairs of leaflet-engagingmembers defining a gap therebetween.

FIG. 50 is a partial side elevation view of another embodiment of asupport frame including a plurality of curved struts that define aleaflet engagement region therebetween.

FIG. 51 is a partial side elevation view of another embodiment of thesupport frame of FIG. 50 wherein the curved struts comprise serrations.

FIG. 52 is a partial side elevation view of another embodiment of asupport frame including a plurality of struts which define leafletcapture regions beneath select apices.

FIG. 53 is a side elevation view of another embodiment of a supportframe in a flattened state including pairs of spring members.

FIG. 54 is a partial side elevation view of the support frame of FIG.53.

FIG. 55 is a partial side elevation view of the support frame of FIG. 53with native valve leaflets engaged between the spring members.

FIG. 56 is a partial side elevation view of an alternative embodiment ofthe support frame of FIG. 53 including spring members configured tooverlap one another.

FIG. 57 is a partial side elevation view of another embodiment of thesupport frame of FIG. 53 including spring members having serrationsorthogonal to the surfaces of the spring members.

FIG. 58 is a partial side elevation view of another embodiment of thesupport frame of FIG. 53 including spring members having serrationsoriented in the direction of the outflow end of the support frame.

FIG. 59A is a partial side elevation view of another embodiment of thesupport frame of FIG. 53 wherein one spring member of each pair ofspring members has circular protrusions and one spring member hascircular cutouts.

FIG. 59B is a partial side elevation view of the support frame of FIG.59A illustrating the circular protrusions of one respective springmember received in the circular cutouts of the other respective springmember.

FIG. 60 is a partial side elevation view of another embodiment of asupport frame including a leaflet-engaging portion.

FIG. 61 is a partial side elevation view of another embodiment of thesupport frame of FIG. 60 in which the leaflet-engaging portion includestwo gaps defined by differences in thickness of the struts.

FIG. 62 is a partial side elevation view of another embodiment of thesupport frame of FIG. 61, in which the leaflet-engaging portion includesbarbs.

FIG. 63 is a partial side elevation view of another embodiment of thesupport frame of FIG. 61, wherein a gap of the leaflet-engaging portioncomprises a tapered shape and one or more barbs.

FIG. 64 is a partial side elevation view of another embodiment of thesupport frame of FIG. 60 comprising serrations.

FIG. 65 is a partial side elevation view of another embodiment of thesupport frame of FIG. 60 comprising a pair of leaflet-engaging wheels.

FIG. 66A is a partial side elevation view of another embodiment of asupport frame including a leaflet-clipping mechanism configured as apair of clipping arms.

FIG. 66B is a partial side elevation view of the support frame of FIG.66A illustrating the leaflet-clipping mechanism in the closed position.

FIG. 66C is a partial side elevation view of the support frame of FIG.66A illustrating the leaflet-clipping mechanism held in the openposition by a delivery device.

FIG. 66D is a partial side elevation view of the support frame of FIG.66A illustrating the leaflet-clipping mechanism engaging a pair ofnative valve leaflets.

FIG. 67A is a partial side elevation view of another embodiment of asupport frame including an elongated member configured as aleaflet-engaging mechanism.

FIG. 67B is a partial side elevation view of the support frame of FIG.67A illustrating the leaflet-engaging mechanism in the closed position.

FIG. 68A is a perspective view of the support frame of FIG. 67Aillustrating the leaflet-engaging mechanisms held in the open positionby a delivery device.

FIG. 68B is a perspective view of the support frame of FIG. 67Aillustrating the leaflet-engaging mechanisms engaging native valveleaflets.

FIG. 69A is a partial side elevation view of another embodiment of asupport frame including a leaflet-engaging mechanism configured as apair of leaflet-engaging members.

FIG. 69B is a partial side elevation view of the support frame of FIG.69A illustrating the leaflet-engaging mechanism in the open position.

FIG. 70A is a perspective view of another embodiment of support frameincluding leaflet-engaging mechanisms configured as pairs ofleaflet-engaging members.

FIG. 70B is a perspective view of the support frame of FIG. 70Aillustrating the leaflet-engaging mechanisms in the open position whenthe support frame is partially deployed from a delivery device.

FIG. 71 is a side elevation view of another embodiment of a supportframe comprising a plurality of branching members definingleaflet-engaging mechanisms.

FIG. 72A is a perspective view of the support frame of FIG. 71 partiallydeployed from a delivery device with the leaflet-engaging mechanisms inthe open position.

FIG. 72B is a perspective view of the support frame of FIG. 71 partiallydeployed from a delivery device with the leaflet-engaging mechanisms inthe closed position.

FIG. 73 is a plan view of the support frame of FIG. 71 implanted in anaortic valve.

FIG. 74A is a side elevation view of another embodiment of a supportframe in a flattened state comprising a plurality of subunits, thesubunits defining leaflet-engaging mechanisms.

FIG. 74B is a side elevation view of the support frame of FIG. 74A in afully expanded configuration.

FIG. 75A is a side elevation view of another embodiment of a supportframe in a flattened state and comprising a plurality of subunits, thesubunits defining leaflet-engaging mechanisms.

FIG. 75B is a side elevation view of the support frame of FIG. 75A in afully expanded configuration.

FIG. 76A is a side elevation view of another embodiment of a supportframe in a flattened state and comprising a plurality of subunits, thesubunits defining leaflet-engaging mechanisms.

FIG. 76B is a side elevation view of the support frame of FIG. 76A in aflattened state illustrating the leaflet-engaging mechanisms in the openposition.

FIG. 77A is a partial perspective view of another embodiment of asupport frame comprising one or more leaflet-engaging mechanismsincluding pairs of struts.

FIG. 77B is a perspective view of the support frame of FIG. 77A.

FIG. 77C is a plan view illustrating an alternative embodiment of thesupport frame of FIG. 77A located in a native heart valve.

FIG. 78 is a perspective view of another embodiment of support framecomprising leaflet-clipping mechanisms configured as clipping armslocated on the interior of the support frame.

FIG. 79 is a perspective view of another embodiment of a support framecomprising leaflet-clipping mechanisms configured as clipping armslocated on the exterior of the support frame.

FIG. 80 is a side elevation view of a clipping arm.

FIG. 81 is a side elevation view of a portion of an actuation assemblyof a delivery device.

FIG. 82A is a perspective view of the support frame of FIG. 78illustrating a portion of an actuator assembly engaged with a clippingmechanism and showing an actuator assembly catheter in a retractedposition.

FIG. 82B is a perspective view of the support frame of FIG. 78illustrating a portion of an actuator assembly engaged with a clippingmechanism and showing an actuator assembly catheter in an advancedposition.

FIG. 83 is a perspective view illustrating the support frame of FIG. 78coupled to a delivery device.

FIG. 84 is a side elevation view of a portion of an alternativeembodiment of an actuator member.

FIG. 85 is a side elevation view of a portion of another alternativeembodiment of an actuator member.

FIG. 86 is a perspective view of another embodiment of the support frameof FIG. 78 intended for use with the actuator member of FIG. 85.

FIG. 87 is a side elevation view of an embodiment of a delivery devicefor use with the support frame of FIG. 78.

FIG. 88 is a perspective view of the support frame of FIG. 78 engagedwith the delivery device and illustrating the clipping members in theclosed position.

FIG. 89A is a perspective view of another embodiment of an outer sheathof a delivery device for use with the support frame of FIG. 78.

FIG. 89B is a perspective view of an inner sheath of the delivery deviceof FIG. 88A.

FIG. 90 is a perspective view of another embodiment of a support frame.

FIG. 91 is a cross-sectional side elevation view of another embodimentof a support frame comprising one or more arcuate members implanted inthe aortic root.

FIG. 92 is a plan view illustrating the support frame of FIG. 91implanted in a cross-section of the aorta.

FIG. 93 is a cross-sectional side elevation view of another embodimentof a support frame comprising one or more vertical and horizontalmembers extending into the ascending aorta.

FIG. 94 is a cross-sectional side elevation view of an alternativeembodiment of the support frame of FIG. 93 having horizontal membersthat extend around the two adjacent vertical members.

FIG. 95 is a cross-sectional side elevation view of another alternativeembodiment of the support frame of FIG. 93 having a single verticalmember.

FIG. 96 is a cross-sectional side elevation view of another alternativeembodiment of the support frame of FIG. 93 having horizontal membersthat are centered about respective vertical members without extendingaround adjacent vertical members.

FIG. 97 is a cross-sectional side elevation view of another embodimentof a support frame implanted in the aortic root and including an annularmember located at the sinotubular junction.

FIG. 98 is a cross-sectional side elevation view of another embodimentof a support frame implanted in the aortic root and including aplurality of struts configured to conform to the contours of the aorticsinuses.

FIG. 99A is a perspective view of another embodiment of a support framecomprising a plurality of distally-extending arcuate members.

FIG. 99B is a plan view of the support frame of FIG. 99A.

FIG. 100 is a cross-sectional side elevation view of the support frameof FIG. 99A implanted in the aortic root.

FIG. 101 is a cross-sectional side elevation view of another embodimentof a support frame including a plurality of retaining arms configured toexert pressure against the sinotubular junction and the walls of theaortic sinuses.

FIG. 102 is a cross-sectional side elevation view of another embodimentof a support frame located in the aortic root and comprising a springmember extending into the ascending aorta.

FIG. 103 is a cross-sectional side elevation view of the support frameof FIG. 102 illustrating the spring member connected to the distal endof a delivery device.

FIG. 104 is a cross-sectional side elevation view of another embodimentof a support frame located in the aorta including a first frame and asecond frame interconnected by one or more elongated members.

FIG. 105 is a cross-sectional side elevation view of another embodimentof a support frame located in the aorta and including a first frame anda second frame interconnected by a spring member.

FIG. 106 is a perspective view of another embodiment of a support frameincluding a first frame and a second frame interconnected by a pluralityof interconnecting members.

FIG. 107 is a plan view of the support frame of FIG. 106.

FIG. 108 is a side elevation view of the support frame of FIG. 106.

FIG. 109 is a perspective view of another embodiment of a support frameincluding a semi-annular member supported by vertical members shape setsuch that the semi-annular member has a diameter greater than thediameter of the ascending aorta.

FIG. 110 is a side elevation view of the support frame of FIG. 109located in a cross-section of the aortic root.

FIG. 111 is a perspective view of an alternative embodiment of thesupport frame of FIG. 109 including a semi-annular member shape set tohave a diameter greater than the diameter of the ascending aorta suchthat vertical members supporting the semi-annular member remain verticalin an unconstrained configuration.

FIG. 112 is a side elevation view of the support frame of FIG. 111located in a cross-section of the aortic root.

FIG. 113 is a perspective view of another embodiment of a anotherembodiment of a support frame including a plurality of retaining loops.

FIG. 114 is a side elevation view illustrating the loading of thesupport frame of FIG. 113 onto a delivery device.

FIG. 115 is a partial cross-sectional view of a delivery deviceillustrating the support frame of FIG. 113 loaded thereon.

FIG. 116 is a plot of stress versus strain for the support frame of FIG.113 illustrating the stress exerted by the support frame on atranscatheter heart valve crimped beneath the support frame on adelivery device as the support frame and the transcatheter heart valveare expanded from a radially collapsed state to a radially expandedstate.

FIG. 117 is a cross-sectional side elevation view of the support frameof FIG. 113 located in the aortic root.

FIG. 118 is a plan view of the support frame of FIG. 113 located in across-section of the aortic root.

FIG. 119 is a cross-sectional side elevation view of the support frameof FIG. 113 located in the aortic root and being expanded by a ballooncatheter.

FIG. 120 is a cross-sectional side-elevation view of the support frameof FIG. 113 located in the aortic root and surrounding a transcatheterheart valve.

FIG. 121 is a perspective view of another embodiment of the supportframe of FIG. 113 including a plurality of planar members.

FIG. 122 is a perspective view of another embodiment of a support frameincluding a plurality of leaflet-engaging mechanisms and a plurality ofactuator mechanisms.

FIG. 123 is a side elevation view of a portion of a leaflet-engagingmechanism of the support frame of FIG. 122.

FIG. 124 is a perspective view of the support frame of FIG. 122 coupledto a delivery device and illustrating the support frame in the openposition.

FIG. 125 is a perspective view of the support frame of FIG. 122 coupledto a delivery device and illustrating the support frame in the closedposition.

FIG. 126 is a perspective view of the support frame of FIG. 122 beingimplanted in a cross-section of the aortic root.

FIG. 127 is a perspective view of another embodiment of a support frameincluding an inner clover and an outer clover configured to pinch theleaflets of a native valve therebetween.

FIG. 128 is a side elevation view of the support frame of FIG. 127partially deployed from a delivery device.

FIG. 129 is a side elevation view of the support frame of FIG. 127partially deployed from an alternative embodiment of a delivery deviceincluding a balloon.

FIG. 130 is a perspective view of the support frame of FIG. 130 coupledto a delivery device.

DETAILED DESCRIPTION General Considerations

Disclosed below are representative embodiments of a support structure(sometimes referred to as a “support stent,” “support frame,” “supportband,” or “support loop”) that can be used to secure a prosthetic heartvalve within a native heart valve or reduce the orifice area of a nativeheart valve. For illustrative purposes, embodiments of the supportstructure are described as being used to secure a transcatheter heartvalve (“THV”) in the aortic valve or the mitral valve of a heart. Itshould be understood that the disclosed support structure and THV can beconfigured for use with any other heart valve as well. Also disclosedherein are exemplary methods and systems for deploying the supportstructure and corresponding THV. Although the exemplary methods andsystems are mainly described in connection with replacing an aortic ormitral valve, it should be understood that the disclosed methods andsystems can be adapted to deliver a support structure and THV to anyheart valve. Further, as used herein, the term “coupled” encompassesmechanical as well as other practical ways of coupling or linking itemstogether, and does not exclude the presence of intermediate elementsbetween the coupled items.

For illustrative purposes, certain embodiments of the support structureare described as being used in connection with embodiments of theballoon-expandable THV described in U.S. Patent Application PublicationNos. 2007/0112422 (U.S. application Ser. No. 11/280,063) and2010/0049313 (U.S. application Ser. No. 12/429,040), which is herebyexpressly incorporated herein by reference. It should be understood,however, that this particular usage is for illustrative purposes onlyand should not be construed as limiting. Instead, embodiments of thedisclosed support structure can be used to secure a wide variety of THVsdelivered through a variety of mechanisms (e.g., self-expanding heartvalves, other balloon-expanding heart valves, and the like). Forinstance, any of the embodiments described in U.S. Pat. No. 6,730,118can be used with embodiments of the disclosed support structure. U.S.Pat. No. 6,730,118 is hereby expressly incorporated herein by reference.

The specification and claims sometimes refer to a first catheter being“advanced” relative to a second catheter. It should be noted that thislanguage not only encompasses situations where the first catheter isphysically moved by an operator relative to the second catheter but alsoencompasses situations where the second catheter is physically moved bythe operator relative to the first catheter (e.g., the second catheteris withdrawn over the first catheter, thereby causing the first catheterto be advanced relative to the second catheter). Likewise, thespecification and claims sometimes refer to a first catheter being“withdrawn” relative to a second catheter. It should be noted that thislanguage not only encompasses situations where the first catheter isphysically moved by an operator relative to the second catheter but alsoencompasses situations where the second catheter is physically moved bythe operator relative to the first catheter (e.g., the second catheteris advanced over the first catheter, thereby causing the first catheterto be withdrawn relative to the second catheter).

The described methods, systems, and apparatus should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The disclosed methods, systems, and apparatus are notlimited to any specific aspect, feature, or combination thereof, nor dothe disclosed methods, systems, and apparatus require that any one ormore specific advantages be present or problems be solved.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language set forthbelow. For example, operations described sequentially may in some casesbe rearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods, systems, and apparatus can be used in conjunctionwith other systems, methods, and apparatus.

Repairing Aortic Insufficiency

Embodiments of the support structures, stents, or frames disclosedherein are suitable for repairing aortic valve insufficiency or aorticvalve regurgitation in which the native aortic valve leaflets no longercoapt properly or completely, allowing blood to leak or backflow throughthe aortic valve during diastole. Some of the support structuresdescribed below can repair or improve aortic insufficiency by reducing adiameter of the aortic valve annulus, either an actual diameter or aneffective diameter. Some embodiments of the support structures cliptogether the native aortic valve leaflets at or near the commissures,thereby reducing the effective diameter of the annulus. Some embodimentspull the annulus of the valve radially inwards, thereby reducing theactual diameter by radially overexpanding the support structure,engaging the support structure with one or more structures of the aorticvalve, for example, the native leaflets and/or valve annulus, andallowing the support structure to radially contract to the default size,thereby reducing the diameter of the valve annulus. Some embodiments doboth.

In some cases, the support structure will by itself repair or ameliorateaortic insufficiency by itself. If the function of the valvedeteriorates, for example, over the course of months or years, a THV isthen deployed, using the support structure as a dock therefor, asdescribed in detail below.

Exemplary Embodiments for Replacing Aortic Valves

FIG. 1 is a perspective view showing an exemplary embodiment of asupport stent or frame 10. Support stent 10 has a generally annular ortoroidal body formed from a suitable shape-memory metal or alloy, suchas spring steel, cobalt-chromium alloy (Elgiloy®), or nitinol.Desirably, the material from which the support stent 10 is fabricatedallows the support stent to automatically expand to its functional sizeand shape when deployed but also allows the support stent to be radiallycompressed to a smaller profile for delivery through the patient'svasculature. In other embodiments, however, the stent is not selfexpanding. In these embodiments, and as more fully explained below,other mechanisms for expanding the stent can be used (e.g., a ballooncatheter).

In the illustrated embodiment, the projection of the support stent 10onto an x-y plane has a generally annular or toroidal shape. Theillustrated support stent 10 further defines a number of peaks andvalleys (or crests and troughs) along its circumference. For example,the support stent 10 is sinusoidally shaped in the z direction. In otherembodiments, the support stent 10 is shaped differently in the zdirection (e.g., sawtooth-shaped, ringlet-shaped, square-wave shaped, orotherwise shaped to include peaks and valleys).

The illustrated support stent 10 includes three peaks 20, 22, 24 andthree valleys 30, 32, 34. In the illustrated embodiment, the peaks 20,22, 24 are positioned above the valleys 30, 32, 34 in the z direction.In some embodiments, the peaks have greater radii than the valleys 30,32, 34, or vice versa. For instance, in some embodiments, the projectionof the support stent 10 onto an x-y plane forms a closed shape having avariable radius (e.g., a starfish shape).

The size of the support stent 10 can vary from implementation toimplementation. In particular embodiments, the support stent 10 is sizedsuch that the support stent can be positioned within the aorta of apatient at a location adjacent to the aortic valve, therebycircumscribing the aortic valve. Furthermore, in order to frictionallysecure a prosthetic heart valve in its interior, certain embodiments ofthe support stent 10 have a diameter that is equal to or smaller thanthe diameter of the prosthetic heart valve when fully expanded. Inparticular embodiments, for instance, the support stent can have aninner or outer diameter between 10 and 50 mm (e.g., between 17 and 28mm) and a height between 5 and 35 mm (e.g., between 8 and 18 mm).Furthermore, the thickness of the annular body of the support stent 10may vary from embodiment to embodiment, but in certain embodiments isbetween 0.3 and 1.2 mm.

FIG. 2 is a perspective view of the exemplary support stent 10positioned on the surface of an outflow side of a native aortic valveand further illustrates the shape of the support stent. In particular,it can be seen from FIG. 2 that the valleys 30, 32, 34 of the supportstent 10 are shaped so that they can be placed adjacent to commissures50, 52, 54 of the native leaflets 60, 62, 64 of the aortic valve.Furthermore, in the illustrated embodiment, the peaks 20, 22, 24 areshaped so that they generally approximate or minor the size and shape ofthe leaflets 60, 62, 64 but are slightly smaller and lower than theheight of the leaflets 60, 62, 64 at their tips when the aortic valve isfully opened. In other embodiments, the peaks 20, 22, 24 are oriented sothat they are adjacent to the commissures 50, 52, 54 of the nativeleaflets 60, 62, 64 and the valleys are opposite the apexes of theleaflets 60, 62, 64. The support stent 10 can be positioned in any otherorientation within the aortic valve as well.

It should be understood that the shape of the support stent or frame 10can vary from implementation to implementation. For example, in someembodiments, the support stent is not sinusoidal or otherwise shaped inthe z-plane. In other embodiments, the support stent is shaped as acylindrical band or sleeve. In general, the support stent or frame canbe any shape that defines an interior through which a THV can beinserted, thereby causing the native leaflets of the aortic valve (orother heart valve) to be pinched or securely held between the supportstent and the THV. Furthermore, the support stent can have a morecomplex structure. For example, although the support stent illustratedin FIGS. 1 and 2 is formed from a single annular member (or strut), thesupport stent can comprise multiple annular elements that interlock orare otherwise connected to one another (e.g., via multiple longitudinalmembers).

Returning to FIG. 1, the illustrated support stent 10 also includeretaining arms 21, 23, 25 that can be used to help position and deploythe support stent 10 into its proper location relative to the nativeaortic valve. The retaining arms 21, 23, 25 can have respectiveapertures 26, 27, 28. An exemplary deployment system and procedure fordeploying the support stent 10 using the retaining arms 21, 23, 25 aredescribed in more detail below. The support stent 10 can also have oneor more barbs located on its surface. Such barbs allow the support stent10 to be more securely affixed to the tissue surrounding the stent orthe leaflets of the aorta.

FIGS. 3 and 4 are side views of the distal end portion of an exemplarydelivery apparatus 100 for delivering the support stent 10 to itslocation adjacent the native aortic valve through a patient'svasculature. In particular, FIG. 3 shows the delivery apparatus when thesupport stent 10 is in a compressed, predeployed state, whereas FIG. 4shows the delivery apparatus when the support stent 10 is in adecompressed, deployed state. The delivery apparatus 100 comprises aguide catheter 102 having an elongated shaft 104, whose distal end 105is open in the illustrated embodiment. In other embodiments, the distalend 105 of the guide catheter 102 can be tapered into a conical shapecomprising multiple “flaps” forming a protective nose cone that can beurged apart when the support stent 10 and any interior catheters areadvanced therethrough. Furthermore, for illustrative purposes, the guidecatheter 102 is shown as being partially cut away, thus revealing thecatheters in its interior.

A proximal end (not shown) of the guide catheter 102 is connected to ahandle of the delivery apparatus 100. During delivery of a supportstent, the handle can be used by a clinician to advance and retract thedelivery apparatus through the patient's vasculature. In a particularuse, the delivery apparatus 100 is advanced through the aortic arch of apatient's heart in the retrograde direction after having beenpercutaneously inserted through the femoral artery. The guide cathetercan be configured to be selectively steerable or bendable to facilitateadvancement of the delivery system 100 through the patient'svasculature. An exemplary steerable guide catheter as can be used inembodiments of the disclosed technology is described in detail in U.S.Patent Application Publication No. 2007/0005131 (U.S. patent applicationSer. No. 11/152,288), which is hereby expressly incorporated herein byreference.

The delivery apparatus 100 also includes a stent delivery catheter 108positioned in the interior of the guide catheter 102. The stent deliverycatheter 108 has an elongated shaft 110 and an outer fork 140 connectedto a distal end portion of the shaft 110. The shaft 110 of the stentdelivery catheter 108 can be configured to be moveable axially relativeto the shaft 104 of the guide catheter 102. Furthermore, the shaft 110of the stent delivery catheter 108 can be sized so that its exteriorwall is adjacent to or in contact with the inner wall of the shaft 104of the guide catheter 102.

The delivery apparatus 100 can also include an inner catheter 118positioned in the interior of the stent deliver catheter 108. The innercatheter 118 can have an elongated shaft 120 and an inner fork 138secured to the distal end portion of the shaft 120. The shaft 120 of theinner catheter 118 can be configured to be moveable axially relative tothe shaft 104 of the guide catheter 102 and relative to the shaft 110 ofthe stent delivery catheter 108. Furthermore, the shaft 120 of the innercatheter 118 can be sized so that its exterior wall is adjacent to or incontact with the inner wall of the shaft 110 of the stent deliverycatheter 108. A guide wire (not shown) can be inserted into the interiorof the inner catheter 118. The guide wire can be used, for example, tohelp ensure proper advancement of the guide catheter 102 and itsinterior catheters through the vasculature of a patient.

As best shown in FIG. 5, a stent retaining mechanism is formed from theinner fork 138 attached to the distal end portion of the shaft 120 ofthe inner catheter 118 and the outer fork 140 attached to the distal endportion of the shaft 110 of the stent delivery catheter 108. The innerfork 138 includes a plurality of flexible inner prongs 141, 142, 143(three in the illustrated embodiment) at is distal end corresponding tothe retaining arms 21, 23, 25 of the support stent 10, and a headportion 144 at its proximal end. The outer fork 140 includes a pluralityof flexible outer prongs 145, 146, 147 (three in the illustratedembodiment) at its distal end corresponding to the retaining arms 21,23, of the stent 10, and a head portion 148 at its proximal end. Thedistal end portions of the outer prongs 145, 146, 147 are formed withrespective apertures 155, 156, 157 sized to receive the retaining arms21, 23, 25.

FIG. 6 is a zoomed-in view of one of the retaining arms 21, 23, 25 as itinterfaces with corresponding prongs of the outer fork 140 and the innerfork 138. In this example, retaining arm 21 is shown, though it shouldbe understood that the retaining mechanism is similarly formed for theretaining arms 23, 25. The distal end portion of the outer prong 145 isformed with the aperture 155. When assembled, the retaining arm 21 ofthe stent is inserted through the aperture 155 of the prong 145 of theouter fork and the prong 141 of the inner fork is inserted through theaperture 26 of the retaining arm 21 so as to retain the retaining arm 21in the aperture 155.

Retracting the inner prong 141 proximally (in the direction of arrow152) to remove the prong from the aperture 26 allows the retaining arm21 to be removed from the aperture 155, effectively releasing theretaining arm from the retaining mechanism. For instance, the outerprong 145 and the retaining arm 21 can be formed such that when theinner prong 141 is withdrawn from the aperture 26, the outer prong 145flexes radially inward (downward in FIG. 7) and/or the retaining arm 21of the support stent flexes radially outward (upward in FIG. 7), therebycausing the retaining arm 21 to be removed from the aperture 155. Inthis manner, the retaining mechanism formed by the inner fork 138 andthe outer fork 140 create a releasable connection with the support stent10 that is secure enough to retain the support stent to the stentdelivery catheter 108 and to allow the user to adjust the position ofthe support stent after it is deployed. When the support stent 10 ispositioned at the desired location adjacent to the leaflets of theaortic valve, the connection between the support stent and the retainingmechanism can be released by retracting the inner fork 138 relative tothe outer fork 140, as further described below. In other embodiments,the function of the inner fork and the outer fork can be reversed. Forexample, the prongs of the inner fork can be formed with apertures sizedto receive the corresponding retaining arms of the support stent and theprongs of the outer fork can be inserted through the apertures of theretaining arms when the retaining arms are placed through the aperturesof the prongs of the inner fork.

As best shown in the exploded view in FIG. 5, the head portion 144 ofthe inner fork can be connected to the distal end portion of the shaft120 of the inner catheter 118. In the illustrated embodiment, forexample, the head portion 144 of the inner fork is formed with aplurality of angularly spaced, inwardly biased retaining flanges 154. Anend piece of the shaft 120 can be formed as a cylindrical shaft havingan annular groove 121. On the distal side of the annular groove 121, theshaft 120 can have a collar 122 with an outer diameter that is slightlygreater than the diameter defined by the inner free ends of the flanges154. Thus, the inner fork 138 can be secured to the end piece byinserting head portion 144 of the inner fork onto the end piece of theshaft 120 until the flanges 154 flex inwardly into the annular groove121 adjacent the collar 122, thereby forming a snap-fit connectionbetween the head portion 144 and the shaft 120. The head portion 144 canhave a proximal end that engages an annular shoulder 123 of the shaft120 that is slightly larger in diameter so as to prevent the headportion from sliding longitudinally along the shaft 120 in the proximaldirection.

The head portion 148 of the outer fork can be secured to a distal endportion of the shaft 110 of the stent delivery catheter 108 in a similarmanner. As shown in FIG. 5, the head portion 148 can be formed with aplurality of angularly spaced, inwardly biased retaining flanges 155. Anend piece of the shaft 110 can be formed as a cylindrical shaft havingan annular groove 111. On the distal side of the annular groove 111, theshaft 110 can have a collar 112 with an outer diameter that is slightlygreater than the diameter defined by the free ends of the flanges 155.Thus, the outer fork 140 can be secured to the end piece of the shaft110 by inserting the shaft 110 onto the head portion 148 until theflanges flex inwardly into the groove 111, thereby forming a snap-fitconnection between the head portion 148 and the shaft 110. The headportion 148 can have a proximal end that engages an annular shoulder 123of the shaft 110 that is slightly larger so as to prevent the headportion from sliding longitudinally along the shaft 110 in the proximaldirection.

In FIG. 3, the support stent 10 is shown in a radially compressed statein the interior of the elongated shaft 104 of the guide catheter 102. Inthe radially compressed state, the distance along the z axis between apeak and an adjacent valley of the support stent is greater than thedistance along the z axis between the peak and the adjacent valley whenthe support stent is in it uncompressed state. The distal end portion ofthe shaft 104 can also be referred to as a delivery sheath for the stent10. In this undeployed and compressed state, the prongs of the outerfork 140 and the inner fork 138 of the stent delivery catheter 108 andthe inner catheter 118 engage the retaining arms 21, 23, 25 of thesupport stent 10 in the manner described above with respect to FIGS. 5and 6. To deploy the support stent 10 in the illustrated embodiment(advance the stent from the delivery system), the stent deliverycatheter 108 and the inner catheter 118 are advanced toward the distalend 105 of the guide catheter 102 using one or more control handles ormechanisms (not shown) located at the proximal end of the guide catheter102. This action causes the support stent 10 to be advanced outwardlythrough the distal end 105 of the guide catheter 102 and expand into itsrelaxed, uncompressed state (shown, for example, in FIGS. 1 and 2).

FIG. 4 is a perspective view showing the support stent 10 after it hasbeen advanced from the distal end of the guide catheter 102. As seen inFIG. 4, the support stent 10 now assumes its relaxed, uncompressed shapebut remains connected to the outer fork 140 and the inner fork 138 atits retaining arms 21, 23, 25. In this configuration, the support stent10 can be rotated (in the clockwise or counter-clockwise directions) orrepositioned (in the proximal and distal directions and/or into adifferent position in the x-y plane) into a proper orientation adjacentto its intended target area. For example, the support stent 10 can bepositioned against the upper surfaces of leaflets of the aortic valve inthe manner illustrated in FIG. 2 while the support stent 10 remainsconnected to the delivery system 100 via the retaining arms 21, 23, 25.As more fully illustrated below in FIGS. 7-12, a prosthetic valve (e.g.,a THV) can be delivered to the aortic valve through a transapicalapproach (e.g., through the apex of the heart and through the leftventricle) and deployed within the native valve such that the prostheticvalve is secured in place by frictional engagement between the supportstent, the native leaflets, and the prosthetic valve.

In particular embodiments, the support stent 10 is shaped so that theTHV can be positioned in the interior of the support stent along withthe native leaflets of the aortic valve. More specifically, the supportstent 10 can be shaped such that the native leaflets become trapped orpinched between the support stent 10 and the exterior of the THV whenthe THV is installed. For instance, the diameter of the support stent 10can be equal to or smaller than the maximum diameter of the THV whenfully expanded, thus causing the THV to be frictionally fit to theleaflets of the aortic valve and the support stent 10. This friction fitcreates a solid foundation for the THV that is independent of the stateor condition of the leaflets in the aortic valve. For example, THVs aremost commonly used for treating aortic stenosis, a condition in whichthe leaflets of the aortic valve become hardened with calcium. Thehardened leaflets typically provide a good support structure foranchoring the THV within the aortic annulus. Other conditions may exist,however, in which it is desirable to implant a THV into the aortic valveand which do not result in a hardening of the leaflets of the aorticvalve. For instance, the support stent 10 can be used as a foundationfor a THV when treating patients with aortic insufficiency. Aorticinsufficiency results when the aortic annulus dilates such that theaortic valve does not close tightly. With this condition, the aorticannulus is larger than normal and would otherwise require a large THV.Using a support stent or frame (such as the support stent or frame 10),however, a smaller THV can be used, thereby making the THV deliveryprocess easier and safer. Furthermore, the use of a support stentprotects against displacement of the THV if there is any furtherdilation of the aortic valve.

A support stent can be used to secure a THV in any situation in whichthe aorta or aortic valve may not be in condition to help support theTHV and is not limited to cases of aortic insufficiency. For example, asupport stent 10 can be used in cases in which the aortic annulus is toodilated or in which the leaflets of the aorta are too weak or soft. Thesupport stent can be used to create an anchor for the THV, for instance,in cases in which the native leaflet tissue is too soft because ofexcess collagen in the aorta.

FIGS. 7-13 illustrate one exemplary procedure for deploying the supportstent and securing a THV to the support stent. In particular, FIGS. 7-8are cross-sectional views through the left side of a patient's heartshowing the acts performed in delivering the support stent 10 throughthe aortic arch to the aortic valve. FIGS. 9-13 are cross-sectionalviews through the left side of a patient's heart showing the actsperformed in deploying a THV 250 and having it engage the support stent10. In order to better illustrate the components of the delivery system100, the guide catheter 102 is shown partially cut away in FIGS. 7-13.For the sake of brevity, certain details concerning the delivery systemof the THV 250 are omitted. Additional details and alternativeembodiments of the delivery system for the THV 250 that may be used withthe support stent described herein are discussed in U.S. PatentApplication Publication No. 2007/0112422 (U.S. application Ser. No.11/280,063), which is hereby expressly incorporated herein by reference.

FIG. 7 shows the guide catheter 102 of the delivery system 100 as it isadvanced through the aortic arch 202 into a position near the surface ofthe outflow side of the aortic valve 210. The delivery system 100 can beinserted through the femoral artery of the patient and advanced into theaorta in the retrograde direction. FIG. 7 also shows the stent deliverycatheter 108, the inner catheter 118, and the support stent 10. In FIG.7, the support stent 10 is in its radially compressed, predeploymentstate. Also seen in FIG. 7 are the outer fork 140 and the inner fork138, which couple the radially compressed support stent 10 to the distalends of the stent delivery catheter 108 and the inner catheter 118,respectively.

FIG. 8 shows the support stent 10 after it has been advanced through thedistal end of the guide catheter 102 and assumes its final, uncompressedshape in a position above and adjacent to the aortic valve 210. Thesupport stent 10 can also be placed directly on the surface of theoutflow side of the aortic valve. FIG. 8 shows that the stent deliverycatheter 108 and the inner catheter 118 have been advanced though thedistal end of the guide catheter 102, thereby pushing the support stent10 out of the guide catheter and allowing it to expand into its naturalshape. In particular embodiments, the support stent 10 is rotated andpositioned as necessary so that the support stent generallycircumscribes the aortic valve and so that the peaks of the supportstent are aligned with the tips of the natural leaflets of the aorticvalve 210. Therefore, when the THV is inserted and expanded within theaortic valve 210, the leaflets of the aortic valve will engage at leastthe majority of the surface in the interior of the support stent 10.This alignment will create an overall tighter fit between the supportstent 10 and the THV. In other embodiments, the support stent 10 isrotated and positioned as necessary so that the peaks of the supportstent 10 are aligned with the commissures or other portions of theaortic valve. The position of the guide catheter 102 and the supportstent 10 relative to the aortic valve 210, as well as the position ofother elements of the system, can be monitored using radiopaque markersand fluoroscopy, or using other imaging systems such as transesophagealecho, transthoracic echo, intravascular ultrasound imaging (“IVUS”), oran injectable dye that is radiopaque.

Also seen in FIG. 8 are the prongs of the outer fork 140 and the prongsof the inner fork 138. In the exemplary procedure, the prongs of theouter fork 140 and the inner fork 138 remain secured to the supportstent 10 until the THV is deployed and frictionally engaged to thesupport stent. The inner and outer forks desirably form a connectionbetween the stent 10 and the delivery system that is secure and rigidenough to allow the clinician to hold the stent 10 at the desiredimplanted position against the flow of blood while the THV is beingimplanted.

In FIG. 8, the support stent 10 is self-expanding. In other embodiments,however, the support stent may not be self-expanding. In suchembodiments, the support stent can be made of a suitable ductilematerial, such as stainless steel. In addition, a mechanism forexpanding the support stent can be included as part of the deliverysystem 100. For example, the support stent can be disposed around aballoon of a balloon catheter in a compressed state. The ballooncatheter can have a shaft that is interior to the inner catheter 118.Because the stent 10 is not self-expanding, the distal end portion ofthe guide catheter 102 need not extend over the compressed supportstent. During delivery of the support stent, the support stent, ballooncatheter, inner catheter 118, and stent delivery catheter 108 can beadvanced from the distal end of the guide catheter 102. The balloonportion of the balloon catheter can be inflated, causing the supportstent to expand. The balloon portion can subsequently be deflated andthe balloon catheter withdrawn into the delivery system 100 to removethe balloon from the interior of the support stent while the supportstent remains connected to the inner catheter for positioning of thesupport stent. The delivery of the support stent otherwise proceeds asin the illustrated embodiment using the self-expanding support stent 10.

FIG. 9 shows an introducer sheath 220 passing into the left ventriclethrough a puncture 222 and over a guidewire 224 that extends upwardthrough the aortic valve 210. The clinician locates a distal tip 221 ofthe introducer sheath 220 just to the inflow side of the aortic valve210. The position of the introducer sheath 220 relative to the aorticvalve 210, as well as the position of other elements of the system, canbe monitored using radiopaque markers and fluoroscopy, or using otherimaging systems.

FIG. 10 shows the advancement of the balloon catheter 230 over theguidewire 224 and through the introducer sheath 220. Ultimately, as seenin FIG. 11, the THV 250 is located at the aortic annulus and between thenative aortic leaflets. FIG. 11 also illustrates retraction of theintroducer sheath 220 from its more distal position in FIG. 10.Radiopaque markers may be provided on the distal end of the introducersheath 220 to more accurately determine its position relative to thevalve 210 and balloon 232. In order to better illustrate the componentsof the delivery system for the THV, FIGS. 10-11 do not show the frontthird of the support stent 10 or the corresponding outer and inner prongof the outer fork and the inner fork, respectively. Furthermore, forpurpose of illustrating the relative position of the support stent 10 onthe THV 250, FIGS. 12-13 show the front third of the support stent 10and the front of the THV 250, but do not show the portions of the nativeheart valve that would be secured by the front of the support stent 10.It is to be understood, however, that a corresponding leaflet of thenative heart valve would be secured between the support stent 10 and theTHV 250.

Again, the precise positioning of the THV 250 may be accomplished bylocating radiopaque markers on its distal and proximal ends. In someembodiments, the clinician can adjust the position of the valve 250 byactuating a steering or deflecting mechanism within the balloon catheter230. Furthermore, the rotational orientation of the valve 250 can beadjusted relative to the cusps and commissures of the native aorticvalve by twisting the balloon catheter 230 from its proximal end andobserving specific markers on the valve (or balloon catheter) underfluoroscopy. One of the coronary ostia 280 opening into one of thesinuses of the ascending aorta is also shown in FIG. 11, and those ofskill in the art will understand that it is important not to occlude thetwo coronary ostia with the prosthetic valve 250.

FIG. 11 shows the THV 250 in its contracted or unexpanded state crimpedaround the balloon 232. When the clinician is satisfied of the properpositioning and rotational orientation of the valve 250, the balloon 232is expanded to engage the support stent 10 as seen in FIG. 12. Theengagement of the support stent 10 to the exterior of the THV 250pinches the leaflets of the aortic valve between the support stent andthe THV 250, and thereby secures the THV within the annulus of theaortic valve. Once secured into this position, the inner catheter 118 ofthe delivery system 100 can be retracted, thereby causing the prongs ofthe inner fork 138 to become disengaged from the retaining arms of thesupport stent 10. Once the prongs of the inner fork 138 are disengaged,the prongs of the outer fork 140 can be disengaged from the retainingarms by retracting the stent delivery catheter 108. Once disengaged fromthe support stent, the delivery system 100 can be retracted from theaortic arch and removed from the patient.

It should be noted that the valve 250 can take a variety of differentforms and may comprise an expandable stent portion that supports a valvestructure. The stent portion desirably has sufficient radial strength tohold the valve at the treatment site and to securely engage the supportstent 10. Additional details regarding balloon expandable valveembodiments that can be used in connection with the disclosed technologyare described in U.S. Pat. Nos. 6,730,118 and 6,893,460, both of whichare hereby expressly incorporated herein by reference.

Once the valve 250 is properly implanted, as seen in FIG. 13, theballoon 232 is deflated, and the entire delivery system including theballoon catheter 230 is withdrawn over the guidewire 224. The guidewire224 can then be withdrawn, followed by the introducer sheath 220.Ultimately, purse-string sutures 260 at the left ventricular apex can becinched tight and tied to close the puncture.

FIGS. 14-16 shows another embodiment of a support stent or frame 310that can be used to help secure a THV into the interior of a nativeheart valve, such as the aortic valve. In particular, FIG. 14 is aperspective view of the support stent 310, FIG. 15 is a top view of thesupport stent 310, and FIG. 16 is a side view of the support stent 310.Like support stent 10, support stent 310 has a generally annular ortoroidal body formed from a suitable shape-memory metal or alloy, suchas spring steel, cobalt-chromium alloy (Elgiloy®), or nitinol. Thesupport stent 310 is also radially compressible to a smaller profile andcan self expand when deployed into its functional size and shape. Inother embodiments, however, the support stent 310 is not self expanding.

The support stent 310 includes a generally cylindrical main body portion320 and a rim portion 330. The support stent 310 can be a meshstructure, which can be formed, for example, from multiple elements inwhich approximately half of the elements are angled in a first directionand approximately half of the elements are angled in a second direction,thereby creating a criss-cross or diamond-shaped pattern. In theillustrated embodiment, the rim portion 330 has a greater diameter thanthe main body portion 320 and is formed as an extension at a bottomregion of the main body portion that is folded outwardly from the mainbody portion and back toward a top region of the main body portion. Therim portion 330 thus forms a U-shaped rim or lip around the bottomregion of the support stent 310. In general, the rim portion 330 isdesigned to have a diameter that is slightly larger than the walls ofthe aortic arch that surround the aortic valve. Thus, when the supportstent 310 is delivered to the aortic valve and deployed at the aorta,the rim portion 330 expands to engage the surrounding aorta wall andfrictionally secures the support stent 310. At the same time, the mainbody portion 320 defines an interior into which an expandable THV can beexpanded and which further engages the native leaflets of the aorticvalve. Thus, the main body portion 320 operates in the same manner asthe support stent 10 described above and illustrated in FIGS. 1-12,whereas the rim portion 330 of the support stent 310 operates to securethe support stent in place by engaging the walls of the aorta thatsurround the aortic valve.

As best seen in FIGS. 14 and 16, the support stent 310 further includesretaining arms 321, 322, 323 that can be used to help position anddeploy the support stent 310 into its proper location relative to thenative aortic valve. The retaining arms 321, 322, 323 can haverespective apertures 326, 327, 328. In general, the retaining arms 321,322, 323 are constructed and function in a similar manner as retainingarms 21, 23, 25 described above in the embodiment illustrated in FIGS.1-12.

FIGS. 17-18 illustrate one exemplary procedure for deploying the supportstent 310 and securing a THV 340 within an interior of the supportstent. In particular, FIGS. 17-18 are cross-sectional views through theleft side of a patient's heart showing the acts performed in deliveringthe support stent 310 through the aortic arch to the aortic valve. Forthe sake of brevity, certain details concerning the delivery system ofthe THV 340 are omitted. Additional details and alternative embodimentsof the delivery system for the THV 340 that may be used with the supportstent described herein are discussed in U.S. Patent ApplicationPublication No. 2008/0065011 (U.S. application Ser. No. 11/852,977) andU.S. Patent Application Publication No. 2007/0005131 (U.S. applicationSer. No. 11/152,288), which are hereby expressly incorporated herein byreference.

FIG. 17 shows an outer catheter 352 (which can be a guide catheter) of adelivery system 350 as it is advanced through the aortic arch 302 into aposition near the surface of the outflow side of the aortic valve 304.The delivery system 350 can be inserted through the femoral artery ofthe patient and advanced into the aorta in the retrograde direction.FIG. 17 also shows a stent delivery catheter 354, an inner catheter 356,and the support stent 310. Also seen in FIG. 17 are the outer fork 360and the inner fork 362, which couple the support stent 310 to the distalends of the stent delivery catheter 354 and the inner catheter 356,respectively.

More specifically, FIG. 17 shows the support stent 310 after it has beenadvanced through the distal end of the guide catheter 352 and assumesits final, uncompressed shape in a position adjacent to the aortic valve304. In order to better illustrate the components of the delivery systemfor the THV, FIGS. 17-18 do not show the entire front side of thesupport stent 310 or the corresponding valve leaflet that would besecured by the front side of the support stent 310. It is to beunderstood, however, that in practice the entire support stent 310 wouldexist and engage a corresponding leaflet of the native heart valve.

The support stent 310 can be positioned adjacent to the aortic valve 304so that the rim portion 330 of the support stent engages the wallssurrounding the aortic valve 304 and exerts an outward force againstthose walls, thereby securing the support stent 310 within the aorta.This positioning can be achieved, for example, by advancing the guidecatheter 352 to a position directly adjacent the aortic valve 304 whilethe stent delivery catheter 354 and the inner catheter 356 areundeployed and while the support stent 310 remains in its compressedstate. The guide catheter 352 can then be retracted while the stentdelivery catheter 354 and the inner catheter 356 are held in place,thereby allowing the support stent 310 to expand toward its naturalshape. As with the delivery system 100 described above, the position ofthe guide catheter 352 and the support stent 310 relative to the aorticvalve 304, as well as the position of other elements of the system, canbe monitored using radiopaque markers and fluoroscopy, or using otherimaging systems such as transesophageal echo, transthoracic echo, IVUS,or an injectable dye that is radiopaque.

Once the support stent 310 is positioned into the desired locationadjacent the aortic valve 304, the prongs of the inner fork 362 can bedisengaged from the corresponding apertures of the retaining arms of thesupport stent 310. For example, the inner catheter 356 can be retractedinto the interior of the stent delivery catheter 354, thereby releasingthe support stent 310 from the outer fork 360 and the inner fork 362.The delivery system 350 can then be retracted from the aorta and removedfrom the patient's body.

With the support stent 310 secured to the aortic valve, a THV (such asany of the THVs discussed above) can be introduced. In contrast to theprocedure illustrated in FIGS. 7-13, a delivery system having a deliverycatheter that is advanced through the patient's aorta can be used todeliver the THV. In other words, a transfemoral approach can be used.For instance, any of the exemplary systems and methods described in U.S.Patent Application Publication No. 2008/0065011 (U.S. application Ser.No. 11/852,977) or U.S. Patent Application Publication No. 2007/0005131(U.S. application Ser. No. 11/152,288) can be used with the supportstent 310. Alternatively, the transapical approach shown in FIGS. 7-13can be used.

FIG. 18 shows delivery system 380 comprising an outer catheter 382(which can be a guide catheter) and a balloon catheter 390 extendingthrough the guide catheter. The balloon catheter 390 has a balloon atits distal end on which the THV is mounted. As with the delivery system350, the delivery system 380 can be inserted through the femoral arteryof the patient and advanced into the aorta in the retrograde direction.FIG. 18 further shows a guidewire 392 that has been first inserted intothe patient's vasculature and advanced into the left ventricle. Thedelivery system can then be inserted into the body and advanced over theguidewire 392 until the THV is positioned within the interior of theaortic valve. As shown, the THV is not only in the interior of theaortic valve 304 but also in the interior of the main body portion ofthe support stent 310.

FIG. 18 shows the THV 340 in its contracted (or unexpanded) statecrimped around the balloon portion of the balloon catheter 390. When theclinician is satisfied of the proper positioning, the balloon of theballoon catheter 390 can be expanded such that the THV 340 expands andurges the native leaflets of the aortic valve against the support stent310, thereby securing the THV within the annulus of the aortic valve.Once the THV 340 is properly implanted, the balloon of the ballooncatheter 390 is deflated, and the entire delivery system 380 includingthe balloon catheter is withdrawn over the guidewire 392. The guidewire392 can then be withdrawn.

Other methods of delivering a support stent and THV to the aortic valveor any other heart valve are also possible. For example, in certainembodiments, the support stent and the THV are delivered surgically tothe desired heart valve (e.g., in an open-heart surgical procedure).Furthermore, in certain embodiments in which the support stent and THVare delivered surgically, non-compressible support stents and/or THVsare used.

Exemplary Embodiments for Treating Valve Insufficiency and VesselAneurysms

Aortic insufficiency (AI) can cause dilatation of the ascending aorta,causing aneurisms, as well as the aortic annulus. In order to preventfurther dilatation, embodiments of the present invention provide foranchoring of a deflector that directs blood away from the aneurysm whileat the same time treating the insufficient heart valve.

As shown in FIG. 19, one embodiment of a medical device 410 for treatingAI (or aneurism(s) or defects of any other vessel associated with avalve) includes a support structure 412, a stent 414, a prosthetic valve416 and a deflector 418. The support structure 412 is configured,similar or the same as the support structures described hereinabove, tocooperate with the prosthetic valve 416 to pinch the native valvetherebetween and provide an anchor for the stent 414 which extends intothe aorta and supports the deflector 418 which is positioned to abateblood flow against the aneurysm.

The support structure 412 (stent or frame) includes, for example in FIG.19, peaks 420, 422, 424 and valleys 430, 432, 434 and retaining arms421, 423, 425 defining apertures 426, 427, 428. Similar to the otherembodiments of the support structures disclosed herein, a range ofvariations are possible for anchoring the both the stent 414 and theprosthetic valve 416 and the deflector 418.

As noted above, it should be understood that the shape of the supportstent or frame 410 can vary from implementation to implementation. Forexample, in some embodiments, the support stent is not sinusoidal orotherwise shaped in the z-plane. In other embodiments, the support stentis shaped as a cylindrical band or sleeve. In general, the support stentor frame can be any shape that defines an interior through which a THVcan be inserted, thereby causing the native leaflets of the aortic valve(or other heart valve) to be pinched or securely held between thesupport stent and the THV. Furthermore, the support stent can have amore complex structure. For example, although the support stentillustrated in FIG. 19 is formed from a single annular member (orstrut), the support stent can comprise multiple annular elements thatinterlock or are otherwise connected to one another (e.g., via multiplelongitudinal members).

The prosthetic valve 416 of the embodiment illustrated in FIG. 19 is aTHV that is similar to the one illustrated in FIG. 1. As noted above, itshould be understood, however, that this particular usage is forillustrative purposes only and should not be construed as limiting.Instead, embodiments of the disclosed support structure can be used tosecure a wide variety of THVs delivered through a variety of mechanisms(e.g., self-expanding heart valves, other balloon-expanding heartvalves, and the like). For instance, any of the embodiments described inU.S. Pat. No. 6,730,118 can be used with embodiments of the disclosedsupport structure.

As shown in FIG. 19, the stent 414 is a scaffold that is coupled to thesupport structure 412 and extends from the support structure into theaorta (and over the insufficient portions of the aorta). The stent 414has a proximal end 430, a distal end 432, and a plurality ofinterconnected struts 434 defining a plurality of cells 436.

In FIG. 19, the proximal (with respect to the heart) end 430 of thestent 414 is connected or coupled to the support structure 412 by beingformed therewith or attachment by wires or other supports. For example,the support structure 412 and stent 414, including the plurality ofinterconnected struts 434, may be laser cut from a single metal tube. Asdescribed hereinbelow, coupling may also be by assembly after separateformation, include assembly in vivo as each portion of the medicaldevice 410 is delivered.

Extending from the proximal end 430 in the distal direction is the bodyof the stent 414 that is formed by the interconnected struts 434 thatdefine between them the cells 436. Preferably, the interconnected struts434 are formed to promote flexibility and facilitate delivery throughtortuous paths and extension over the aortic arch. For example, thestrut pattern may be as shown (as a flattened portion of a laser-cutblank prior to expansion) in FIG. 20 and include a plurality of rings438 formed by sinusoidal struts connected end-to-end, wherein the ringsare connected by a plurality of angled, flexible connectors 440. Also,the rings 438 may be formed to have variable lengths and the connectors440 selectively located to promote directional preferences inflexibility and/or variations in cell sizes between them.

An example of a flexible stent structure is the LIFESTENT manufacturedby C.R. BARD, INC. which has a multi-dimensional helical structure thatfacilitates its use in tortuous paths of peripheral vasculature. Aspectsof the LIFESTENT are described in U.S. Pat. No. 6,878,162 entitled“Helical Stent Having Improved Flexibility and Expandability” by Baleset al.

Such flexibility is advantageous for treatment of AI in that the stent414, when extending along the aortic arch, has a tightly curvedconfiguration with an external, long curvature 442 and an internalcurvature 444. Along the external curvature 442 the cell sizes may belarger to allow for the longer path length. These cell sizes may beprogrammed into the stent by selective cutting and formation of thestruts and cells and/or may appear due to the mechanical application ofinsertion and delivery into the aortic arch. Similarly, the internalcurvature 444 may be programmed through selection of the strut structureand/or due to delivery.

In addition, the stent 414 may include structure that facilitatesengagement, frictional or mechanical, of the surrounding lumen (e.g.,the aorta) where the lumen is in adjacent contact with the stent. Forinstance, the struts 434 and cells 436 may have a pattern thatfacilitates frictional engagement, or may have barbs or hooks ormicro-anchors or flared portions formed thereon to mechanically engagethe lumen and facilitate the support structure 412's role of securingthe medical device 410.

The distal end 432 of the stent 414 is positioned within the aortic archdistal the branch (e.g., brachiocephalic, common carotid and leftsubclavian) arteries extending off of the aorta. The distal end 432 maybe a termination of the last row of the rings 438 or may include its ownretaining arms 446 defining apertures 448. Use of the retaining arms 446and apertures 448 enables use of the delivery apparatus 110 shown inFIGS. 3 and 4 and described hereinabove. The distal end 432 may alsoinclude structure configured to engage the surrounding lumen walls foradditional security of the medical device 410. For example, it mayinclude hooks or barbs or micro anchors.

In another aspect, the cells 436 may include a relatively large cellstructure positioned over and near the branch arteries. This facilitatesperfusion of the branch arteries, such as by being located over thebranch arteries at the aortic arch or closer to the valve forcommunication with the coronary arteries. The cell structure isrelatively large in comparison to the remaining cells configured tosupport the lumen walls or abate blood flow against aneurysms or furthervascular dilatation. In another aspect, the cell size may be selected toguard the branch arteries against embolic debris, so as to act as apartial deflector of such debris.

The length of the device 410, including the support structure 412 andstent 414, may be enough to extend from the native leaflets, through thesinus of valsalva, into the ascending aorta, over the aortic arch andpotentially into the descending aorta. For example, the length of thedevice 410 may be 30 mm to 100 mm or longer. The stent 414 may also betapered, small at the annulus to larger at the ascending aorta, columnaror have ends that are a larger diameter for sealing and anchoring, asshown in FIG. 21.

Once this support structure 412 and stent 414 are deployed they act likea scaffold or anchoring device for other devices to be deployed insideof it, such as the prosthetic valve 416, which is delivered and anchoredas described above, and one or more deflectors 418.

In FIG. 19, the deflector 418 is a covered stent or graft that isrelatively impermeable (e.g. to blood flow and is configured forpositioning over an aneurysm in the aortic arch so as to direct bloodflow away from the aneurysm. The deflector 418 of the embodiment of FIG.19 includes a deflector stent 450 supporting a tubular graft material452 extending around the deflector stent. The deflector 450 is mountedwithin the stent 414 as would a graft being fit within a vessel withoutthe stent 414. For example, the deflector 450 may be delivered by acatheter extending retrograde to blood flow within the aorta, orextending from the heart chamber and through the aortic valve, and thenexpanded (or allowed to expand) once the desired location is reached.

Advantageously, the stent 414 guards the aneurysm against the expansionpressure of the deflector 418 and the deflector can have a much smallerexpanded diameter than the aneurysm and still is assured of a firmanchor.

Deployment of the medical device 410 of FIG. 19 may include firstdeploying the support structure 412 and the stent 414 (if they'reintegrally attached to each other). Then, through the support structure412 and the sent 414 the THV prosthetic valve 416 is delivered,anchoring it into the proximal end of the device (either the supportstructure 412 or the stent 414). The covered stent or graft deflector418 is deployed in the stent 414, covering the area that has theaneurysm and avoiding the branch arteries and associated larger cells436 of the stent 414. The deflector 418 would then redirect thepulsating blood away from the aneurysm so as to prevent dissection, andthe new valve prosthesis 416 would ensure that correct blood flow isrestored.

Although the deflector 418 is shown in FIG. 19 as being a single graftor covered stent, the term “deflector” should be construed broadlyherein to include any structure that serves to abate (reduce) blood flowagainst the selected portion of the vessel wall. For example, multipledeflectors 418 in the form of grafts or covered stents could bedelivered and positioned to address anatomical variations in size andpositioning of the aneurysm(s). Also, the deflector 418 need not be atubular structure but could be a sheet or shield of material anchored toone side of the stent 414. Also, the deflector 418 need not beseparately attached, but could be a portion of the stent 414 withreduced permeability, such as through a polymeric coating. FIG. 21 showsanother example wherein the stent 414 is covered with a deflector 418 atthe time of delivery.

FIG. 22 shows another example wherein the stent 414 is covered with adeflector 418 in the form of a balloon 454. The balloon not onlydeflects blood flow, but also can be inflated so as to expand into andfill the space between the stent 414 and the aneurysm wall. Inflationmay be by fluid, such as saline wherein the balloon may include aone-way check valve that stops outflow of the saline after detachment ofthe inflation lumen. Also, inflation may be by a polymer or other fluidthat sets or cures or thickens and can therefore maintain the fill shapeafter intervention is complete. Preferably, the expansion forces of theballoon 454 are sufficiently low so as to not further expanded theaneurysm but at the same time cause the balloon to take the shape of theaneurysm space. The balloon, therefore, may be comprised of a verypliable material such as a silicone that expands under low pressureand/or may even include a woven material. For woven materials, anotheradvantage is that the woven material may have a limit to expansion andwill protect the aneurysm from dissection if the woven balloon isfashioned to fit the aneurysm.

FIG. 23 shows another example wherein the stent 414 is covered with adeflector 418 in the form of a foam sleeve 456. The foam may be an opencelled foam or a closed-cell foam that promotes friction with thesurrounding lumen at initial implantation. If open celled the blood willin-grow and create a barrier for the blood not to pass along the aorticwall. The foam may be configured for up to 300% compression.

Also, the foam may be configured, such as by being hydrophilic, toabsorb and expand in blood and fill the space between the stent 414 andthe lumen. A skin or impermeable layer can be also applied to the stent414 or foam sleeve 456 so that the foam does not peel/break off andcause an embolism. The skin or impermeable layer inhibits seep of thepassing blood through the foam to the aortic wall. For example, an innersurface of the foam sleeve 456 may have a relatively impermeable skin(such as a closed cell foam) to promote passage of blood therethroughwhile the outer surface is open celled and permeable for expansion.

The foam may also have coagulation properties that promote buildup ofclots to help secure the medical device 410 and fill the aneurismalspace. The foam may include, for example, a flexible ester polyurethane,reticulated open cell, felted foam with a pore size of 80-100 ppi, adensity of 5.4-6.3 pcf. Also, thick woven sleeves may be used thatexpand in response to absorbing blood, such as a hydrophilic weave orfoam.

During delivery, the foam sleeve 456 is crimped down with the stent 414and then placed in the aorta of the patient. Upon expansion, the stent414 expands and maintains its more rigid shape, whereas the foam canalso expand and take up the current shape of the aorta. The foamadvantageously fills the void between the stent 414 and the aneurysmwall, preventing blood (the continued pulse force) from reaching theaneurysm. The foam sleeve 456 creates a seal within the aorta forcingblood to be passed through the stent 414 diameter. It also has effectivefriction or outward forces on the aortic wall so as to restrictmovement.

FIG. 24 shows another example wherein the deflector 418 has an annulusor donut shape, such as a foam or balloon annulus. With its reducedlength, the donut may be positioned at the location of the aneurysm,thereby blocking the flow of blood to this particular section of theaortic wall.

FIG. 25 shows another example including two donut or annulus shapeddeflectors 418 on the stent 414 which aid in retention of the devicewithin the aorta. In this variation, donuts may be placed on oppositesides of the aneurysm and seal the aneurysm against blood flow. Thedonuts may be foam, balloons or other expansion members. There may beseveral (more than two) of the annulus deflectors depending up thenumber and positioning and size of the aneurysms.

As shown in FIG. 28, the deflector 418 may include micro anchorsattached to the foam or balloon section to aid in retention if theexpansion force of the foam or balloon is not suitable in larger aortas.

In another aspect, the deflector 418 may include mechanical clotfacilitators such as wires, coils or springs that fill the space betweenthe stent 414 and the aneurysm walls to promote embolizationtherebetween.

FIG. 26 shows another embodiment of the present invention wherein thedeflector 418 (in the form of a graft) may include a seal 458 in theform of a slit configured to allow passage into the interior of thestent 414. For example, the seal 458 may include overlapping portions orlips of the graft material that self-seal by closing up after removal ofdelivery tool. Or, the seal may be a valve, such as a duckbill valve.

The graft 418 with the seal 458 may be used in a during a “trans-aortic”THV implantation wherein the graft is first deployed in a percutaneousdelivery. The THV is then delivered through the chest wall with adelivery tool (e.g., a catheter) and through a slit in the aorta(aortotomy) and finally through the slit or seal 458 in the graft. Theslit then seals around the delivery tool to prevent blood loss. The THVis expanded into place within the support structure 412 or stent 414.The seal 458 closes when the delivery tool is removed, allowing theaorta to be sutured without blood escaping. The graft 418 could be leftbehind—or it could be retrieved after completion of the procedure. Sucha seal 458 may be employed in a range of embodiments with the deflector418, including the embodiments disclosed herein.

FIG. 27 shows another embodiment wherein the deflector 418 has anhourglass shape and is constructed of a resilient material that deflectsin response to increased blood pressure of a heart beat and addsadditional pumping action as the arterial pressure drops. For example,the hourglass shape is formed of resilient walls that deflect underpressure and spring back into shape as the pressure drops. In anotheraspect, the walls of the graft may be relatively thick for an increasedresiliency and additional pumping action.

In another embodiment, two anchoring stents may be connected by anelastic tube (e.g., made out of silicone). One of the anchors isdeployed in the STJ (right above the native valve) and the other anchoris deployed on the other end of the aneurysm somewhere in the ascendingaorta prior to the branches. The elasticity of the tube would aid theheart's pumping action.

Preferably, each of the medical devices 410 described herein is capableof a large amount of compression. For example the device 410, includingthe embodiment of the stent 414 and its foam sleeve 456, can becompressed or crimped to a diameter that is 8 mm or less. Uncompressed,the diameter may be 50 mm to 90 mm.

A method of using the medical device 410 disclosed herein includesdelivering the support structure 412 to a position on or adjacent to thesurface of the outflow side of the native heart valve of the patient,wherein the support structure defines a support-structure interior. Theexpandable prosthetic heart valve 416 is delivered into the native heartvalve and into the support-structure interior. The expandable prostheticheart valve 416 is expanded while it is in the support-structureinterior and while the support structure is at the position on oradjacent to the surface of the outflow side of the native heart valve.This causes one or more of the native heart valve leaflets to befrictionally secured between the support structure 412 and the expandedprosthetic heart valve 416.

The stent 414, which is coupled to the support structure 412 either byco-formation or later attachment, is extended into a vessel (such as theaorta) extending from the native heart valve. The deflector 418 isalready present on the stent 414 and/or is delivered into and attachedto the stent 414. Blood flow against the vessel is abated by thedeflector 418.

The method also may include delivering the stent 414 (or portionsthereof) to a position adjacent the support structure 412 and couplingit to the support structure prior to extending the stent into thevessel. Also, the deflector 418 may be delivered to a support positionon the stent 414 and coupled to the stent in vivo. Further, in the casewhere the stent 414 has a plurality of portions, the portions could beindividually delivered and coupled to each other in vivo. Preferably,the method includes avoiding arteries extending from the vessel whenpositioning the deflector.

Also, the method may include expanding the deflector 418 to fill atleast a portion of the space between an external surface of the stent414 and the vessel.

FIG. 29 shows another embodiment of a support stent or frame 500 thatcan be used to treat valve insufficiency (e.g., aortic insufficiency,mitral insufficiency, etc.), or to help secure a THV within the interiorof a native heart valve. The support stent 500 comprises an annular mainbody 501 formed by a plurality of angled struts 502 arranged in azig-zag pattern and having one or more apices 504 formed by theintersection of two adjacent struts. The struts 502 can be configuredsuch that there is a gap 506 between adjacent struts underneath theapices 506 that receives portions of two adjacent leaflets forming acommissure of a native valve, as shown in FIG. 30. In particularembodiments, the support stent has a gap 506 for each commissure of thenative valve where the support stent is to be implanted. Thus, as shownin FIGS. 29 and 30, when the support stent 500 is intended to beimplanted at the aortic valve or the pulmonary valve, the support stent500 desirably has three, angularly spaced gaps 506, with each gap beingpositioned at a commissure of the native valve when the support stent500 is implanted. The gaps 506 can be dimensioned to pinch or clampadjacent leaflets to each other at respective commissures. Similarly, ifthe support stent is configured to be implanted at the native mitralvalve, the support stent desirably has two gaps 504. In this manner, thesupport stent 500 can retain or clamp the native valve leafletstogether, thereby reducing the effective orifice area of the valvewhich, in turn, can reduce regurgitation through the valve.

If the stent 500 alone does not sufficiently reduce regurgitation or ifthe native valve further deteriorates over time after implantation ofthe stent 500, a THV can be deployed within the native valve, using astent 500 as dock as shown in FIGS. 10-13. In some embodiments, thestent 500 and the THV can be implanted in the same procedure, using thestent 500 as the dock for the THV. As can appreciated, as compared tothe implantation steps shown FIGS. 1-13, use of the stent 500 simplifiesthe procedure since the stent 500 can “clip” onto the commissures of thenative leaflets and retain its position once deployed, which obviatesthe need to hold the stent in place using one catheter while the THVimplanted using another catheter as is shown in FIG. 12.

Referring to FIGS. 31 and 32, the support stent 500 can also be used totreat native valve insufficiency by reducing the diameter of the valveannulus. The support stent 500 can be anchored in the valve annulus byone or more microanchors 508 comprising one or more sets of barbs 510.Exemplary embodiments of microanchors that can be used with thedisclosed technology can be found in U.S. patent application Ser. No.13/910,975 (U.S. Publication No. 2013/0331930), which is incorporatedherein by reference. As shown in FIG. 31, the microanchors 508 can bepositioned in the gaps 506 adjacent the apices 504 of the support stentand can be embedded in the tissue of the valve annulus. One or moresutures 512 coupled to the microanchors 508 can extend upwardly toward adelivery system (not shown) and can comprise one or more suturesecurement devices, such as a suture clip 514. The suture clip 514 canbe configured to travel along the sutures 512 in the direction indicatedby arrow 516 (i.e., toward the microanchors 508). As tension is appliedto the sutures 512 (by pulling upwardly on sutures and/or pushingdownwardly on the suture clip) the suture clip can resist travel of thesutures 512 through the suture clip 514 in the opposite direction (i.e.,the suture clip can resist downward travel of the sutures relative tothe clip). Exemplary embodiments of suture securement devices that canbe used with this technology can be found in U.S. patent applicationSer. No. 13/938,071 (U.S. Publication No. 2014/0031864), which isincorporated herein by reference.

Once the microanchors 508 are implanted in the tissue of the valveannulus, tension can be applied to the sutures 512 such that themicroanchors 508 are drawn toward one another, thereby reducing thediameter of the valve annulus (FIG. 32). The suture clip 514 retainstension on the sutures 512, thereby retaining the support stent and thesurrounding tissue in the reduced diameter state after implantation. Inthis manner, the support stent 500 can be used to reduce the diameter ofthe valve annulus.

In other embodiments, the support stent 500 can be implanted in aprocedure in which the microanchors 508 are deployed adjacent thecommissures of the native valve with each microanchor 508 being providedwith a suture 512 that can extend to a delivery apparatus and/or outsidethe body. When implanting at the native aortic valve, three microanchors508 (each having a respective suture) can be implanted. The sutures 512can be threaded through openings in the apices 504 of the support stent500, which can then be advanced along the sutures until it is placedagainst the aortic surface of the native leaflets. A suture clip 514 canbe advanced down the sutures 512 to tension the sutures and draw thesurrounding tissue inwardly to reduce the diameter of the native annulus(as depicted in FIGS. 31-32).

In alternative embodiments, the support stent 500 can be made of aself-expanding material (e.g., Nitinol) and is delivered and deployedusing an expansion mechanism (e.g., a balloon catheter). When thesupport stent 500 is adjacent the native valve, the expansion mechanismover expands the support stent (i.e., expands the support stent radiallybeyond its functional size) (such as by inflating the balloon of theballoon catheter) and places the support stent against the aorticsurface of the native valve. The support stent 500 can have barbs oranchors 508 can that engage, penetrate and/or grab adjacent tissue asthe support stent 500 is placed against the native tissue. In lieu of orin addition to barbs or anchors, the support stent 500 can be configuredto clip onto commissures of the native valve when the commissures areplaced in gaps 506. The expansion mechanism then releases the supportstent 500 (such as by deflating the balloon), allowing the support stentto shrink/return to its natural or functional size, pulling thesurrounding tissue inwardly to reduce the size of the native annulus.

Alternatively, the aortic annulus can be reduced in size by suturing thesupport stent 500 in its functional size to the aortic valve.

FIG. 33 shows another embodiment of a support stent or frame 600 thatcan be used to treat heart valve insufficiency or help secure a THVwithin the interior of a native heart valve, such as the aortic valve.The support stent 600 comprises an annular main body 601 formed by aplurality of angled struts 602 arranged in zig-zag pattern. The supportframe 600 can include one or more leaflet-engaging mechanisms 603. Theleaflet-engaging mechanisms 603 can comprise pairs of leaflet-engagingmembers 604 secured to respective struts 602 below one or more apices606 formed by the intersection of the two adjacent struts 602. Eachleaflet-engaging member 604 has a fixed end portion 608 secured to arespective strut and a free end portion 610. The leaflet-engagingmembers 604 extend upwardly toward the apex 606 and toward each other.In their normal, unbiased (i.e., non-deflected) state, theleaflet-engaging members 604 can be configured such that there is asmall gap between respective free end portions 610 that receivesportions of two adjacent leaflets 616 forming a commissure of a nativevalve, as further described below. The struts 602 and theleaflet-engaging members 604 can be laser cut (or otherwise machined orformed) from a single piece of material (e.g., a tubular piece of metal)such that the leaflet-engaging members 604 are integral to the supportstent. In other embodiments, the leaf springs 604 can be separatelyformed and welded to the struts 602.

In particular embodiments, the support stent has a pair ofleaflet-engaging members 604 for each commissure of the native valvewhere the support stent is to be implanted. Thus, as shown in FIG. 33,when the support stent 600 is intended to be implanted at the aorticvalve or the pulmonary valve, the support stent 600 desirably has three,angularly spaced pairs of leaflet-engaging members 604, with each pairbeing positioned underneath an apex 606 that is positioned at acommissure of the native valve when the support stent 600 is implanted.If the support stent is configured to be implanted at the native mitralvalve, the support stent desirably has two pairs of leaflet-engagingmembers 604. Although less desirable, in some embodiments, the number ofpairs of leaf springs can be less than the number of commissures of thenative valve where the support stent is to be implanted. Similar to thesupport stent 310, the support stent 600 can have retaining arms 612 forreleasably securing the support stent 600 to a delivery apparatus (e.g.,delivery apparatus 350).

FIG. 34 shows the support stent 600 implanted in the aortic root behindthe leaflets 616 of an aortic valve 614. To deliver and deploy thesupport stent at the implantation site, the support stent 600 can bemounted in a compressed state on a delivery apparatus 350 (FIG. 17) anddelivered to the vicinity of the native aortic valve, as described indetail above. When the support stent 600 is adjacent the aortic valve614 (e.g., within or just above the aortic root), the support stent 600can be deployed from the catheter 352, allowing the support stent toexpand to its functional size. Each pair of leaflet-engaging members 604is rotationally aligned within one of the commissures of the aorticvalve. Thereafter, the delivery apparatus 350 is further advanced towardthe aortic valve, causing each pair of leaflet-engaging members 604 toslide over a pair of native leaflets 616 of one the commissures of theaortic valve. The gap between the free end portions 610 of the leafsprings is such that insertion of the native leaflets 616 can place theleaf springs in tension and pinch the native leaflets between the leafsprings. Once the native leaflets are captured by the support stent 600,the support stent can be released from the delivery apparatus 350. Thecompressive force of the leaflet-engaging members 604 against the nativeleaflets 616 is sufficient to hold the support stent 600 in placeagainst the flow of blood. Thereafter, if desired, a THV can beimplanted within the interior of the aortic valve 614 (as shown in FIG.18) and expanded against the native leaflets 614, which in turn arepressed radially outwardly against the support stent.

FIG. 35 shows a modification of the support stent 600 havingleaflet-engaging members 604 with spherical free end portions 618 thatare configured to contact each other in their normal, unbiased(non-deflected) state. The curved outer surfaces of the spherical freeend portions 610 can help to engage the native leaflets placed betweenthe spherical free end portions 618 without damaging the leaflets.During insertion of native leaflets between the leaflet-engaging members604, the leaflet-engaging members 604 can flex such that the sphericalfree end portions 618 move upwardly and away from each other to allowthe leaflets to slide between the spherical free end portions 618 (asdepicted in FIG. 35).

FIG. 36 shows another modification of the support stent 600 havingleaflet-engaging members 604 with curved free end portions 620, whichcan enhance the retention force against the leaflets while minimizingbulkiness of the leaflet-engaging members 604. FIG. 37 shows the supportstent of FIG. 36 implanted within the aortic root with a pair ofleaflets 616 captured between the free end portions 620 of theleaflet-engaging members 604.

FIG. 38 shows another modification of the support stent 600 having asingle leaflet-engaging member 604 below one or more selected apices606. In this embodiment, the leaflet-engaging member 604 is configuredto capture a pair of leaflets 616 between a spherical free end portion618 of the leaflet-engaging member 604 a protrusion 622 extending towardthe leaflet-engaging member 604. In the embodiment shown, the protrusion622 is shaped to snag or bind against the adjacent leaflet 616 to helpretain the leaflets 616 in place between the leaflet-engaging member 604and the protrusion. In alternative embodiments, the leaflets 616 can becaptured between the spherical free end portion 618 of theleaflet-engaging member 604 and the surface of an adjacent strut 602.

FIG. 39 illustrates another modification of the support frame 600,wherein the leaflet-engaging members 604 are configured to extend fromdistal apices 624 formed by the intersection of two adjacent struts 602at the outflow end of the support frame 600.

FIG. 40 shows another embodiment of support stent 700 comprising anannular main body 701 (shown flattened) formed by a plurality of struts702. Positioned beneath one or more selected apices 704 of the supportstent are leaflet-engaging mechanisms 705 comprising pairs ofleaflet-engaging members 706 configured to capture a respective pair ofnative leaflets. In the illustrated embodiment, each leaflet-engagingmember 706 has a first end 708 secured to a strut 702 and a second end710 secured to the same strut 702. Each leaflet-engaging member 706 canhave a plurality of curved sections 712 extending between the first andsecond ends 708, 710, respectively, allowing adjacent leaflet-engagingmembers 706 of a pair to deflect away from each other while a pair ofnative leaflets are inserted therebetween. Each pair of leaflet-engagingmembers 706 can also apply sufficient compressive force against theleaflets once they are in place between the leaflet-engaging members 706such that the leaflets are retained between the leaflet-engaging members706. In the embodiment shown, the leaflet-engaging members 706 can beconfigured to define a small gap between the curved sections 712 ofadjacent members 706. In alternative embodiments, the curved sections712 can define points of contact that can contact corresponding contactpoints of an adjacent member 706 when the members 706 are in theirnon-deflected state.

FIG. 41 illustrates another embodiment of a support frame 800 shown in aflattened or unrolled state for purposes of illustration. The supportframe 800 comprises an annular main body 801 formed by a plurality ofstruts 802, and one or more leaflet-engaging mechanisms 803. Theleaflet-engaging mechanisms 803 can comprise pairs of semi-annularleaflet-engaging members 804 positioned beneath respective apices 806 ofthe support frame. Each leaflet-engaging member 804 in the illustratedembodiment comprises first and second fixed end portions 808, 810secured to a respective strut 802 and a peak 812 formed by a portion ofthe leaflet-engaging member 804 intermediate the two fixed end portions808, 810. In the embodiment shown, the leaflet-engaging members 804 canextend generally in the direction of the outflow end of the supportframe 800 such that the first fixed end portion 808 is closer to theapex 806 than is the peak 812. FIG. 42 shows the support frame 800implanted in the aortic root 814 with the native leaflets 816 of theaortic valve 818 captured between respective pairs of leaflet-engagingmembers 804.

FIG. 43 shows another embodiment of a support stent 900 comprising aplurality of struts 902 and a plurality of leaflet-engaging mechanisms903. The leaflet-engaging mechanisms 903 can comprise clipping members904 secured to distal apices 916 of the struts 902 at the inflow end ofthe support stent 900. FIG. 44 shows a clipping member 904 apart fromthe support stent 900. Each clipping member 904 comprises two legportions 906 secured to each other at an apex 908. Each leg portion 906has a free end portion 910 that can be angled inwardly toward the otherfree end portion 910 as shown. Each clipping member 904 can be securedto the support frame 900 with a section of fabric cloth 912 that extendsaround the apex 908 of the clipping member 904 and an adjacent distalapex 916 of the support frame 900 at the inflow end of the supportframe. Sutures can be used to secure the cloth 912 in place around theclipping member 904 and the adjacent distal apex 916 of the supportframe 900. As can be seen in FIGS. 43 and 45, two leg portions 906 ofadjacent clipping members 904 can extend toward each other for capturinga pair of native leaflets 914.

In some embodiments, the clipping members 904 can be separately formedfrom the support frame 900, and can be fabricated from metal wire havinga diameter that is smaller than the diameter of the struts 902. Forexample, in some embodiments, the diameter of the clipping members 904can be from about 0.010 inch to about 0.023 inch. Each leg portion 906of the clipping members 904 can also have a length L of, for example, 5mm or greater (FIG. 46). In this manner, the clipping members 904 can beconfigured to apply an inward retaining force Fin on the aortic valveleaflets, as shown in FIGS. 45 and 46. In some embodiments, theretaining force F_(in) can be about 3 N. The clipping members 904 canalso have a removal force F_(R) needed to remove or reposition thedevice 900 along the leaflets 914, and a buckling force F_(B) orientedaxially with respect to struts 902. The removal force F_(R) and thebuckling force F_(B) can be configured such that the application of therequired removal force F_(R) can result in a buckling force F_(B)sufficient to cause the clipping members 904 to bend or buckle, thusreducing the risk of tearing the native valve leaflets 914 whenrepositioning or removing the support frame 900. In some embodiments,the removal force F_(R) can be about 6 N. In alternative embodiments,the clipping members 904 can be integrally formed with the support frame900.

FIG. 47 shows another embodiment of support stent 1000 comprising anannular main body formed by a plurality of struts 1002. Positionedbeneath one or more selected apices 1004 of the support stent 1000 areleaflet-engaging mechanisms 1003 comprising horseshoe-shapedleaflet-engaging members 1006 configured as clips corresponding to eachof the three commissure locations of the native aortic valve. Each ofthe leaflet-engaging members 1006 can be configured to capture arespective pair of native leaflets at each commissure of the aorta. Theleaflet-engaging members 1006 and support frame 1000 can be integrallymanufactured or separately manufactured and subsequently assembled usingany suitable method or combination of, for example, welding, tying withsuture or wire, adhesive, mechanically fastening, and the like. In thisapplication, the phrases “integrally manufactured,” “integrally formed,”and “integral to” all refer to a construction that does not include anyadhesive, fasteners, or other means for securing separately formedpieces of material to each other.

FIGS. 48 and 49 illustrates fragmentary views of another embodiment of asupport frame 1100 comprising an annular main body formed by a pluralityof struts 1102. The support frame 1100 can comprise one or moreleaflet-engaging mechanisms 1103 including a pair of integratedleaflet-engagement members 1104. The leaflet-engaging members 1104 canbe positioned beneath selected apices 1106 and can be configured tocapture respective pairs of native leaflets. In the illustratedembodiment, each leaflet-engaging member 1104 has a first end 1108secured to a strut 1102 and a second end 1110 secured to the same strut1102. Each leaflet-engaging member 1104 can be spring-biased, allowingadjacent leaflet-engaging members 1104 of a pair to deflect away fromeach other when a pair of native leaflets are inserted between theleaflet-engaging members 1104. The leaflet-engaging members 1104 can beconfigured to apply force against the leaflets such that the leafletsare retained between the leaflet-engaging members 1104.

In the embodiment of FIG. 48, the curved leaflet-engaging members 1104can define points of contact that contact corresponding contact pointsof an adjacent member 1104 when the members 1104 are in theirnon-deflected state. Alternatively, the members 1104 can be configuredto define a small gap between the curved sections of adjacent members1104, as shown in FIG. 49. The members 1104 can also have diametersgreater than, equal to (FIG. 49), or less than (FIG. 48) the diameter ofthe struts 1102 depending on, for example, the degree of spring-biasdesired.

FIGS. 50 and 51 illustrate a fragmentary view of another embodiment of asupport stent 1200 comprising an annular main body formed by a pluralityof struts 1202. Beneath one or more selected apices 1204, the struts1202 can be curved or otherwise shaped such that adjacent struts definea leaflet-engaging mechanism 1203 having a narrow leaflet-engagementregion 1206 between the struts 1202. The leaflet-engagement region 1206can comprise a gap dimensioned to grip the native aortic valve leaflets.The struts 1202 can be spring-biased, allowing adjacent pairs of struts1202 to deflect away from each other when a pair of native leaflets areinserted between the struts 1202, and causing the struts 1202 to applyforce against the leaflets sufficient to retain the leaflets in placebetween the struts 1202. In some embodiments, the leaflet-engagementregion 1206 can include teeth or serrations 1208 configured to engagethe native leaflets, thereby helping to keep the frame 1200 in placeafter implantation.

FIG. 52 shows another embodiment of a stent 1300 comprising an annularmain body formed by a plurality of struts 1302. The support frame 1300can include leaflet-engaging mechanisms 1303 located beneath selectapices 1304 and defined by the struts 1302. The struts 1302 can beseparated by narrow leaflet-engagement regions 1306. Theleaflet-engagement regions 1306 can comprise serrations 1308 configuredto engage native leaflets when they are inserted between the struts1302. In this manner, the stent 1300 can be held in place afterimplantation.

Referring to FIGS. 53-55 there is shown another embodiment of a supportframe 1400 comprising an annular main body 1401 (shown flattened in FIG.53) formed by a plurality of struts 1402. The support frame 1400 cancomprise one or more leaflet-engaging mechanisms 1403, which can includea pair of leaflet-engaging members 1404 secured to respective struts1402 below one or more apices 1406 formed by the intersection of twoadjacent struts 1402. Each leaflet-engaging member 1404 can have a fixedend portion 1408 secured to a respective strut 1402 and a free endportion 1410. The leaflet-engaging members 1404 can extend downwardlyfrom near the apices 1406 at the outflow end of the support frame 1400and toward each other, defining a narrow leaflet-engaging region 1405,before curving toward the struts 1402 near the inflow end of the frame1400. As best shown in FIG. 54, in their normal, unbiased(non-deflected) state, the leaflet-engaging members 1404 can beconfigured such that there is a small gap between free end portions 1410and the struts 1402. In this manner the leaflet-engaging members 1404can deflect toward adjacent struts 1402 when the leaflets 1414 of anative valve are inserted therebetween, as shown in FIG. 55. As withembodiments previously described, the struts 1402 and theleaflet-engaging members 1404 can be laser cut (or otherwise machined orformed) from a single piece of material (e.g., a tubular piece of metal)such that the leaflet-engaging members 1404 are integral to the supportstent. Alternatively, the leaflet-engaging members 1404 can beseparately formed and welded to the struts 1402.

In the embodiment shown, the support frame 1400 can comprise a pair ofleaflet-engaging members 1404 located beneath each apex 1406 of theframe. This can make implantation of the support frame 1400 easier byreducing the amount by which the frame 1400 must be rotated in order toline up the pairs of leaflet-engaging members with the commissures ofthe native valve. Alternatively, the support frame 1400 can have a pairof leaflet-engaging members 1404 for each commissure of the native valvewhere the support frame is to be implanted. Thus, similar to theembodiment of FIG. 33 above, when the support frame 1400 is intended tobe implanted at the aortic valve or the pulmonary valve, the supportframe 1400 desirably has three, angularly spaced pairs ofleaflet-engaging members 1404, with each pair being positionedunderneath an apex 1406 that is positioned at a commissure of the nativevalve when the support frame 1400 is implanted. Similarly, if thesupport frame 1400 is configured to be implanted at the native mitralvalve, the support frame 1400 desirably can have two pairs ofleaflet-engaging members 1404. Although less desirable, in someembodiments, the number of pairs of leaflet-engaging members 1404 can beless than the number of commissures of the native valve where thesupport stent is to be implanted. Similar to the support stent 310, thesupport stent 1400 can also have retaining arms 1412 (FIG. 53) forreleasably securing the support stent 1400 to a delivery apparatus(e.g., delivery apparatus 350).

FIG. 56 shows a modification of the support stent 1400 havingleaflet-engaging members 1404 that overlap one another in their normal(non-deflected) state. In this manner, the leaflet-engaging members 1404can be configured to retain the native valve leaflets 1414 by applying apreload to the leaflets 1414 once they are captured between theleaflet-engaging members 1404. In the embodiment shown, the overlappingregion of the leaflet-engaging members 1404 is offset from a centralaxis 1416 extending though apex 1406, and the respective fixed endportions 1408 of the leaf springs are vertically offset from oneanother. Alternatively, the respective leaflet-engaging members 1404 canoverlap symmetrically about the central axis 1416 of the stent, and thefixed end portions 1408 can be fixed to the respective struts 1402 atthe same vertical position. In the embodiment shown, the free endportions 1410 of the leaflet-engaging members 1404 contact the struts1402 when the leaflet-engaging members 1404 are in their non-deflectedstate. Alternatively, the free end portions 1410 can be spaced from thestruts 1402 such that there is a gap between the free end portions 1410and the struts 1402, depending upon the degree of spring bias desired inthe leaflet-engaging members 1404.

FIGS. 57 and 58 show another modification of the support frame 1400having leaflet-engaging members 1404 that comprise or serrations 1418located in the leaflet engagement region 1405. The serrations 1418 canbe defined by circular cutouts 1420 such that the serrations 1418 extendoutwardly from the leaflet-engaging members 1404 in a directiongenerally orthogonal to the surface of the leaflet-engaging members1404, as shown in FIG. 57. The serrations 1418 can aid in retaining thenative leaflets between the leaflet-engaging members 1404 afterinsertion. Alternatively, the leaflet-engaging members 1404 can compriseangled cutouts 1422 such that the serrations 1418 are oriented generallyin the direction of the outflow end of the support frame 1400, as shownin FIG. 58. In this manner, the serrations 1418 can allow smoothinsertion of the native leaflets between the leaflet-engaging members1404 (i.e., the orientation of the serrations 1418 can minimize damageto the leaflets caused by the serrations 1418 during insertion) whileretaining the native leaflets after insertion between theleaflet-engaging members 1404. In further alternative embodiments, theleaflet-engaging members 1404 can comprise surface roughness in theleaflet-engagement region 1405 to increase retention of the native valveleaflets.

FIGS. 59A and 59B show another modification of the support stent 1400wherein respective leaflet-engaging members 1404 of each pair compriseprotrusions 1424 and corresponding cutouts or recesses 1426 configuredto receive the protrusions 1424. In some embodiments, theleaflet-engaging members 1404 can be spring-biased to move between anopen position (FIG. 59A), wherein the respective leaf springs define agap therebetween, and a closed position (FIG. 59B), wherein the recesses1426 receive the protrusions 1424 of the corresponding leaflet-engagingmember 1404. In this manner, native valve leaflets inserted between theleaflet-engaging members 1404 when the leaflet-engaging members 1404 arein the open position can be engaged and retained between the protrusions1424 and the recesses 1426 of the respective leaflet-engaging members1404 when the leaflet-engaging members 1404 are in the closed position.

FIG. 60 shows a detail view of another embodiment of a stent 1500comprising an annular main body formed by a plurality of struts 1502.Beneath apices 1504, the support frame 1500 can comprise aleaflet-engaging mechanism 1503 in the form of a leaflet-engagingportion 1505 defined by the struts 1502. The leaflet-engaging portion1505 can define a gap 1506 configured to engage and retain native valveleaflets 1508 after insertion of the leaflets into the gap 1506. Theleaflet-engagement portion 1505 can include a cloth or fabric covering1510 surrounding the respective struts 1502 and extending over the apex1504. The fabric covering 1510 can be configured to engage the nativeleaflets 1508 when the leaflets are inserted into the gap 1506. Thefabric covering 1510 can be configured to reduce wear and/or damage tothe native leaflets, as well as to accommodate different leafletthicknesses. Cloth or fabric is optionally included in any embodiment ofthe support frames disclosed herein at any location where tissue damageor wear is likely to occur.

FIG. 61 shows a modification of the stent 1500 having aleaflet-engagement portion 1505 that defines a first gap 1506 and asecond gap 1514, with the first gap 1506 being narrower than the secondgap 1514. The first gap 1506 can be defined by an increase in thicknessof the respective struts 1502 in the region of the first gap 1506, andcan comprise serrations 1516 on the respective struts 1502. The firstgap 1506, together with the serrations 1516, can aid in retaining thenative leaflets 1508 after insertion into the leaflet-engaging portion1505. In some embodiments, the struts 1502 can have a uniform firstthickness except for the portion of the respective struts 1502 thatdefine the first gap 1506, where the thickness of the struts 1502 canincrease to a second thickness that is greater than the first thicknessbefore returning to the first thickness in the region defining thesecond gap 1514. In alternative embodiments, the struts 1502 can have athird thickness in the region defining the second gap 1514 that is lessthan the first thickness, as shown in FIG. 62.

FIG. 63 shows another modification of the stent 1500 wherein the firstgap 1506 has a tapered shape, with the distance between respectivestruts 1502 decreasing from the inflow end of the first gap 1506 to theoutflow end of the first gap 1506. The leaflet-engaging portion 1505 canalso include one or more projections or barbs 1518 located on respectivestruts 1502 and extending into the first gap 1506 and or the second gap1514. For example, as shown in FIG. 63, the leaflet-engaging portion1505 can include barbs 1518 located on respective struts 1502 at theinflow end of the first gap 1506, and barbs 1518 located on the outflowend of the first gap 1506 and oriented generally in the direction of thesecond gap 1514. In this manner, the support frame 1500 can be retainedin place after insertion of the native leaflets 1508 in theleaflet-engaging portion 1505. In alternative embodiments, theleaflet-engaging portion 1505 need not include barbs, or the barbs maybe smooth projections rather than pointed projections.

In another alternative embodiment of the support frame 1500, the struts1502 can define a single gap 1506 in the leaflet-engaging portion 1505,as shown in FIG. 64. The gap 1506 can comprise cutouts or serrations1516 extending from the distal end of the gap 1506 to the proximal end,or any suitable length therebetween.

FIG. 65 is a detail view of another embodiment of a support frame 4200comprising an annular main body formed by a plurality of angled struts4202. The support frame 4200 can include a leaflet-engaging mechanism4203 comprising a pair of toothed or notched wheels 4204 rotatablysecured to a leaflet-engaging portion 4206 of the frame 4200 below anapex 4212 defined by the intersection of the struts 4202. In theillustrated embodiment, each wheel 4204 can have an easy direction ofrotation (indicated by arrows 4208), which permits native leaflets 4210to easily enter the leaflet-engaging portion 4206 of the support frame4200. Rotating each wheel 4204 in an opposite direction is moredifficult, thereby tending to keep the leaflets 4210 engaged in theleaflet-engaging portion 4206. Some embodiments of the wheels 4204 cancomprise a soft or elastomeric material contacting the leaflets 4210,thereby reducing wear or damage thereto. Some embodiments can includeonly one wheel 4204, which can engage the leaflets 4210 between thewheel 4204 and a strut 4202 of the leaflet-engaging portion 4206.

FIGS. 66A-66D are detail views of another embodiment of a support frame1600 comprising an annular main body formed by a plurality of struts1602. The frame 1600 can include one or more active leaflet-clippingmechanisms 1604 comprising two clipping arms 1606 movable between anopen position (FIG. 66A) and a closed position (FIG. 66B). In someembodiments, the clipping arms 1606 can be biased towards the closedposition. The clipping arms 1606 can comprise respective proximal endportions 1608, intermediate portions 1610, and distal leaflet-engagingportions 1612. In the embodiment shown, the proximal end portions 1608include holes or eyelets 1614 configured to receive wires or flexibleprongs (e.g., flexible prongs 141 of the delivery system 350). In thismanner, the clipping arms 1606 can be held in the open position whenmounted on a delivery apparatus prior to implantation, as furtherdescribed below.

The intermediate portions 1610 can include connecting members 1616coupled to the struts 1602 of the stent 1600. In the embodiment shown,the connecting members 1616 can be coupled to the struts on or adjacentto the apices 1618 of the struts 1602. However, the connecting members1616 can be coupled to the struts 1602 at any suitable location alongthe length of the struts. The connecting members 1616 can act asfulcrums about which the clipping arms 1606 pivot when moving betweenthe open and closed positions.

The leaflet-engaging portions 1612 can be configured to engage thenative leaflets 1622 when the clipping arms 1606 are in the closedposition, as shown in FIGS. 66C and 66D. In the embodiment shown, theleaflet-engaging portions 1612 include projections 1620 configured toengage and retain the native leaflets 1622 between the clipping arms1606. Alternatively, the leaflet-engaging portions 1612 can include anysuitable type of surface treatment to aid in retaining the leaflets 1622between the clipping arms 1606 such as cutouts, serrations, surfaceroughness, etc. In further alternative embodiments, the leaflet-engagingportions 1612 may not include any surface treatment.

The struts 1602 and the one or more leaflet-engaging mechanisms 1604 canbe laser cut (or otherwise machined or formed) from a single piece ofmaterial (e.g., a tubular piece of metal) such that the leaflet-engagingmechanisms 1604 are integral to the support stent. In other embodiments,the leaflet-engaging mechanisms 1604 can be separately formed and weldedor otherwise coupled to the struts 1602. In some embodiments, theleaflet-engaging mechanisms 1604 can be located on the interior of thestent annulus. Alternatively, the leaflet-engaging mechanisms 1604 canbe located on the exterior of the stent annulus.

[Advantages?]

After fabrication of the stent, the clipping arms 1606 can be arrangedon respective sides of the struts 1602, with the connecting memberscoupled to the struts, as shown in FIG. 66A. The clipping arms 1606 canthen be shape set such that the clipping arms are biased toward theclosed position, as shown in FIG. 66B. Prior to insertion into apatient, the flexible prongs 141 of the delivery system 350 can bethreaded through the apertures 1626 of the retaining arms 1624 andthrough the holes 1614 of the clipping arms such that the clipping arms1606 are held in the open position, as shown in FIG. 66C. Afterpositioning the stent over and around the valve leaflets 1622, theflexible prongs 141 can be retracted through the holes 1614, releasingthe clipping arms 1606. The clipping arms 1606 can then move to theclosed position, capturing the leaflets 1622 between respectiveleaflet-engaging portions 1612 of the clipping arms, as shown in FIG.66D. The flexible prongs 141 can then be retracted through the apertures1626 of the retaining arms 1624, and the delivery system 350 can bewithdrawn, leaving the stent secured to the leaflets 1622 in the nativevalve.

FIGS. 67A, 67B, 68A, and 68B illustrate another embodiment of a supportframe 1700 comprising an annular main body 1701 formed by a plurality ofstruts 1702. The stent 1700 can include one or more activeleaflet-engaging mechanisms 1704 comprising an elongated member 1706configured to move between an open position (FIG. 67A) and a closedposition (FIG. 67B), in a direction indicated by arrow 1724. In theembodiment shown, the elongated member 1706 can comprise a proximal endportion 1708 having an eyelet or hole 1710, and a distal end portion1712 coupled to an apex 1714 of the stent and/or the base of a retainingarm 1716. In the embodiment shown, the elongated member 1706 can bedisposed in an opening 1726 defined by the retaining arm 1716 when theelongated member 1706 is in the open position, and can move out of theopening 1726 when moving to the closed position.

In some embodiments, the proximal end portion 1708 of the elongatedmember 1706 can be curved radially inward (i.e., curved in a directiontoward the center of the valve annulus), as shown in FIG. 67B.Alternatively, the proximal end portion 1708 can be straight orotherwise conform to the vertical profile of the retaining arms 1714, asshown in FIG. 67A. The distal end portion 1712 can comprise a springportion 1718, which can be shape set such that the elongated member 1706is biased toward the closed position, as shown in FIG. 67B.

The leaflet-engaging mechanisms 1704 can be integrally formed (e.g., bylaser cutting, machining, or forming) with the stent 1700 from a singlepiece of material (e.g., a piece of metal). Alternatively, theleaflet-engaging mechanisms 1704 can be separately formed and welded orotherwise coupled to the stent 1700. When the support frame 1700 isintended to be implanted at the aortic valve or the pulmonary valve, thesupport stent 1700 desirably has three, angularly spacedleaflet-engaging mechanisms 1704, with each mechanism being positionedat a commissure of the native valve when the support stent 1700 isimplanted, as shown in FIGS. 68A and 68B. Similarly, if the supportstent is configured to be implanted at the native mitral valve, thesupport stent desirably has two leaflet-engaging mechanisms 1704.

Prior to implantation, the elongated member 1706 can be shape set suchthat it is biased toward the closed position, as described above. Theflexible prongs 141 of the delivery system 350 can be threaded throughthe apertures 1720 of the retaining arms 1716 and through the holes 1710of the elongated member 1706 such that the elongated member is held inthe open position, as shown in FIG. 68A. Referring to FIG. 68B, afterpositioning the stent over and around the valve leaflets 1722 (shown inphantom), the prongs 141 can be retracted through the holes 1710,releasing the elongated members 1706. The elongated members 1706 canthen move to the closed position, engaging and retaining the leaflets1722 between struts 1702, as shown in FIG. 66D. The prongs 141 can thenbe retracted through the apertures 1720 of the retaining arms 1716, andthe delivery system 350 can be withdrawn, leaving the stent secured tothe leaflets 1722 in the native valve.

FIGS. 69A and 69B show a detail view of another embodiment of a supportframe 1800 comprising an annular main body formed by a plurality ofstruts 1802. The stent 1800 can include one or more activeleaflet-engaging mechanisms 1804 comprising a pair of leaflet-engagingmembers 1806 secured to respective struts 1802. The leaflet-engagingmembers 1806 can be movable between an open position, as shown in FIG.69B, and a closed position, as shown in FIG. 69A. Each leaflet-engagingmember 1806 can have a fixed end portion 1808 secured to a respectivestrut 1802 and a free end portion 1810. The leaflet-engaging members1806 can extend distally from the struts 1802 toward the inflow end ofthe frame 1800 and toward one another, such that the free end portions1810 are substantially coincident when the leaflet-engaging members 1806are in the closed position. In the embodiment shown, the fixed endportions 1808 of the leaflet-engaging members 1806 are secured to thestruts 1802 at the midpoint of the struts. However, in alternativeembodiments, the leaflet-engaging members 1806 can be secured to thestruts 1802 at any suitable location. In the illustrated embodiment, thefree end portion 1810 of each leaflet-engaging member 1806 comprises afoot 1814 that can be directed towards the received leaflets (notshown), which can aid in retaining the leaflets between theleaflet-engaging members 1806. In alternative embodiments, the free endportions 1810 can comprise other leaflet-engaging features such asbarbs, serrations, cutouts, hooks, surface roughness, etc.

The open and closed positions can correspond to a radially collapsedstate and a radially expanded state of the frame 1800, respectively. Forexample, when the frame 1800 is in a radially collapsed state, such aswhen loaded or partially deployed from a delivery catheter, the struts1802 can be circumferentially displaced toward one another, as shown inFIG. 69B. Circumferential displacement of the struts 1802 toward oneanother can cause the free end portions 1810 of the leaflet-engagingmembers 1806 to be circumferentially displaced away from one another,thereby defining a leaflet-engagement region 1812 between the free endportions 1810 of the respective leaflet-engaging members 1806. Duringimplantation, the frame 1800 can be partially deployed from the deliverycatheter and positioned such that the native valve leaflets (not shown)are located in the leaflet-engagement regions 1812 of the respectiveleaflet-engaging mechanisms 1804. The frame 1800 can then be fullydeployed from the delivery catheter, causing the frame 1800 to expand toits functional size and causing the leaflet-engaging members 1806 to becircumferentially displaced to the closed position (causing the endportion 1810 to move toward each other, FIG. 69A), thereby engaging theleaflets at or near their commissures between the free end portions 1810of the members 1806.

FIGS. 70A and 70B show a perspective view of another embodiment of asupport frame 1900 comprising an annular main body 1901 formed by aplurality of struts 1902. The frame 1900 can comprise one or moreleaflet-engaging mechanisms 1903 comprising pairs of leaflet-engagingmembers 1904 extending circumferentially between alternating first andsecond apices 1906 a, 1906 b. Each leaflet-engaging member 1904 cancomprise a fixed end portion 1908 coupled to a first apex 1906 a, anintermediate portion 1910 coupled to an adjacent second apex 1906 b, orto the struts 1902 immediately below the second apex 1906 b, and a freeend portion 1912 disposed beneath the second apex 1906 b. The pairs ofleaflet-engaging members 1904 can be configured to move between an openposition (FIG. 70B) and a closed position (FIG. 70A) corresponding to apartially deployed (i.e., a partially radially collapsed) configurationand a fully deployed configuration of the stent 1900, respectively.

In the illustrated embodiment, the intermediate portions 1910 of theleaflet-engaging members 1904 can comprise peaks 1918 locatedapproximately equidistant between the first and second apices 1906 a,1906 b. The peaks 1918, along with the relatively long length of theintermediate portions 1910, can provide the leaflet-engaging members1904 with some resiliency or flexibility which, in concert with thecurved contact area, can reduce the risk of damage to the leaflets. Thefree end portions 1912 of the leaflet-engaging members 1904 of eachrespective pair can define a leaflet-engaging region or gap 1914dimensioned to engage and retain the leaflets (not shown) of a nativeheart valve. In the embodiment shown, the free end portions 1912 of theleaflet-engaging members 1904 can define a curved leaflet contact area1920, which can reduce the risk of damage to the leaflets. In someembodiments, the leaflet contact areas 1920 can include surfacetreatment such as projections, cutouts, surface roughness, etc., to aidin retaining the leaflets between the leaflet-engaging members.

In the embodiment shown, the first apices 1906 a can comprise retainingarms 1916. In this manner, as the stent is deployed from a deliverycatheter 1922, the second apices 1906 b can emerge from the deliverycatheter 1922 first, while the retaining arms 1916 of the first apices1906 a remain within the lumen of the delivery catheter 1922, as shownin FIG. 70B. This can cause the retaining arms 1916 and the associatedfirst apices 1906 a to flex radially inward, in turn drawing the struts1902 of the second apices 1906 b apart. This can cause the free endportions 1912 of the leaflet-engaging members 1904 to be drawn into theopen position, allowing the leaflets to be inserted in theleaflet-engaging region 1914. Once situated about the leaflets, theretaining arms 1916 can be fully deployed from the delivery catheter1922, allowing the frame 1900 to expand to its functional size andcausing the leaflet-engaging members 1904 to move into the closedposition, engaging and retaining the native leaflets. In someembodiments, the curved free end portions 1912 of the leaflet-engagingmembers 1904 can be configured to contact the leaflets in both the openand closed configurations, which can permit the leaflet-engaging members1904 to roll into place as the support frame expands to the closedconfiguration, thereby reducing the risk of damage to the nativeleaflets.

The leaflet-engaging members 1904 can be integrally formed with thestent 1900, or can be separately formed and secured to the stent by,e.g., welding, brazing, adhesive, etc. In the embodiment shown, thefixed-end portions 1908 are integrally formed with the first apices 1906a, while the intermediate portions 1910 are welded to the radiallyoutward-facing surfaces of the struts 1902 of the second apices 1906 b.In alternative embodiments, the fixed-end portions 1908 and theintermediate portions 1910 can both be integrally formed with therespective first and second apices 1906 a, 1906 b, or the fixed endportions 1908 and the intermediate portions 1910 can be separatelyformed and secured to the respective apices 1906 a, 1906 b as describedabove.

FIGS. 71, 72A, 72B, and 73 illustrate another embodiment of a supportframe 2000 comprising an annular main body 2001 having a plurality ofleaflet-engaging mechanisms configured as frame subunits 2002 formed bya corresponding number of branching members 2004. The frame subunits2002 can comprise an actuator portion 2006 and a leaflet-engagingportion 2008. The leaflet-engaging portion 2008 can comprise twoleaflet-clipping subunits 2010 movable between an open position (FIG.72A) and a closed position (FIGS. 71 and 72B) by actuation of theactuator portion 2006. In the embodiment shown, the frame 2000 includesthree frame subunits 2002 formed by three respective branching members2004, and interconnected by connecting members 2012.

Referring to the frame subunit 2002 shown fully in FIG. 71, the actuatorportion 2006 can comprise a peak 2014 and a valley 2016. The peak 2014can be formed by the intersection of a first branch 2018 and a secondbranch 2020 of the branching member 2004 at a proximal end of theactuator portion 2006. The first and second branches 2018, 2020 of thebranching member 2004 can be arcuate, and can further branch into thirdand fourth branches 2022, 2024, and fifth and sixth branches 2026, 2028,respectively. The valley 2016 can be defined by the convergence of thefourth and fifth branches 2024, 2026 of the branching member 2004 near aproximal end of the leaflet-engaging portion 2008. In the embodimentshown, the fourth and fifth branches 2024, 2026 converge toward oneanother, but do not intersect to form a single integral member. However,in alternative embodiments, the fourth and fifth branches 2024, 2026 canintersect to form an integral member, as desired. In the embodimentshown, the peak 2010 can further comprise a retaining arm 2011.

The leaflet-clipping subunits 2010 can each have a peak 2030 and avalley 2032. The peaks 2030 can be formed by the respective proximalintersections of the third and fourth branches 2022, 2024, and the fifthand sixth branches 2026, 2028, respectively, of the branching member2002. Similarly, the valleys 2032 can be formed by the respective distalintersections of the third and fourth branches 2022, 2024, and the fifthand sixth branches 2026, 2028, respectively. The respective peaks 2030of the leaflet-clipping subunits 2010 can be angled away from oneanother such that the leaflet-clipping subunits 2010 are biased towardthe closed position when the frame is in the fully expandedconfiguration. In this manner, the leaflet-clipping subunits 2010 can beconfigured to engage and retain native leaflets 2038 between therespective leaflet-clipping subunits 2010 when the frame 2000 isdeployed in a native valve 2034, as shown in FIG. 73. The fourth andfifth branches 2024, 2026 can also be interconnected by a spring member2036, which can aid in biasing the leaflet-clipping subunits 2010 towardthe closed position.

The support frame 2000 can be configured such that when partiallydeployed from the end of a delivery catheter 2040 with the actuatorportions 2006 of the respective frame subunits 2002 within the catheterand the leaflet-clipping subunits 2010 outside the catheter, radialcompression of the actuator portions 2006 can actuate or lever theleaflet-clipping subunits 2010 into the open position, as shown in FIG.72A. In this manner, a user can position the support frame 2000 over thecommissures 2042 of the native valve leaflets 2038 such that theleaflets are located between respective leaflet-clipping subunits 2010of the leaflet-engaging portions 2008. As the support frame 2000 is morefully deployed, the radial compression of the actuator portions 2006 canbe released, causing the leaflet-clipping subunits 2010 to close,capturing the leaflets 2038 of the native valve 2034 therebetween, asshown in FIG. 73. Partially retracting the support frame 2000 back intothe catheter 2040 can reopen the leaflet-clipping subunits 2010 byapplying radial compression to the actuator portion 2006, permitting theuser to reposition the device. FIG. 72B is an illustration of thesupport frame partially deployed from the delivery catheter 2040 withthe leaflet-clipping subunits 2010 intermediate the open and closedpositions. FIG. 73 is a top view of the support frame fully deployed inan aortic valve 2034.

The branching members 2004 of the support frame can be laser cut (orotherwise machined or formed) from a single piece of material (e.g., atubular piece of metal) such that the frame subunits 2002 are integralto the support stent. In other embodiments, the various branches of thebranching members 2004 can be separately formed and welded or otherwisecoupled together to form the frame subunits 2002. In further alternativeembodiments, respective frame subunits can be integrally formed and thenjoined together by, for example, welding, brazing, adhesives, etc.

FIGS. 74A and 74B illustrate another embodiment of a support frame 2100comprising an annular main body 2101 including a plurality ofleaflet-engaging mechanisms configured as frame subunits 2102. The framesubunits 2102 can be formed by a plurality of first and second framemembers 2104, 2106 configured as retaining arms. FIG. 74A is a sideelevation view of a flattened layout pattern of the support frame 2100,while FIG. 74B illustrates the support frame 2100 in a fully expandedconfiguration. The frame subunits 2102 can comprise an actuator portion2108 and a leaflet-engaging portion 2110. The leaflet-engaging portion2110 can comprise two leaflet-clipping subunits 2112 movable between anopen position and a closed position by actuation of the actuator portion2108, similar to the embodiment of FIG. 71. In the embodiment shown, theframe 2100 includes three frame subunits 2102, although the frame caninclude any suitable number of frame subunits depending upon the valvestructure into which the frame is to be implanted.

Each of the first frame members 2104 can comprise first and secondinternal branches 2114, 2116, which can define the actuator portions2108 of the respective frame subunits 2102, as further described below.Each of the second frame members 2106 can comprise first and secondexternal branches 2118, 2120, which can define respective boundaries ofthe leaflet-engaging portions 2110. In the embodiment shown, the framesubunits 2102 can be bounded by respective second frame members 2106.

The actuator portion 2108 can comprise a peak 2122 and a valley 2124.The peak 2122 can be formed by the intersection of the first internalbranch 2114 and the second internal branch 2116 of the first framemember 2104 at a proximal end of the first frame member 2104. The firstand second internal branches 2114, 2116 of the first frame member 2104can be symmetrically arcuate, and can intersect one another at anintersection 2126 located at a distal end of the actuator portion 2108,thereby defining the valley 2124 of the actuator portion 2108. In theembodiment shown, the intersection 2126 can act as a lever, causing theleaflet-clipping subunits 2112 to move to the open position when radialcompression is applied to the first and second internal branches 2114,2116 of the actuator portion 2106. In alternative embodiments, the firstand second internal branches 2114, 2116 of the first frame member 2104need not intersect.

Referring to the leaflet-engaging portion 2110, the first and secondinternal branches 2114, 2116 of the first frame member 2104 can continueto extend distally from the intersection 2126 to a distal end of theleaflet-engaging portion 2110 where they can intersect the first andsecond external branches 2118, 2120 of the second frame member 2106 toform valleys 2128 of the respective leaflet-clipping subunits 2110. Thefirst internal branches 2114 and the second external branches 2120, andthe second internal branches 2116 and the first external branches 2118,can be interconnected by respective interconnecting members 2130. Theinterconnecting members 2130 can define peaks 2132, which can be angledaway from one another. In this manner, the interconnecting members 2130can act as springs biasing the leaflet-clipping subunits 2112 toward theclosed position when the stent 2100 is in the fully expandedconfiguration. In this manner, the leaflet-clipping subunits 2112 can beconfigured to engage and retain native valve leaflets between therespective leaflet-clipping subunits when the frame is deployed in anative valve.

The support frame 2100 can be configured such that when partiallydeployed from the end of a catheter with the actuator portions 2108 ofthe respective frame subunits 2102 within the catheter and theleaflet-clipping subunits 2112 outside the catheter, radial compressionof the actuator portions 2108 can actuate or lever the leaflet-clippingsubunits 2112 into the open position, similar to the embodiment of FIG.71. In this manner, a user can position the support frame 2100 over thecommissures of the native valve leaflets such that the leaflets arelocated between respective leaflet-clipping subunits 2112 of theleaflet-engaging portions 2110. As the support frame 2100 is more fullydeployed, the radial compression of the actuator portions 2108 can bereleased, causing the leaflet-clipping subunits 2112 to move to theclosed position, capturing the leaflets of the native valvetherebetween. Partially retracting the support frame 2100 back into thecatheter can reopen the leaflet-clipping subunits 2112 by reapplyingradial compression to the actuator portions 2108, permitting the user toreposition the device.

The first and second frame members 2104, 2106 of the support frame 2100can be laser cut (or otherwise machined or formed) from a single pieceof material (e.g., a tubular piece of metal) such that the framesubunits 2102 are integral to the support stent. In other embodiments,the various branches of the first and second frame members 2104, 2106can be separately formed and welded or otherwise coupled together toform the frame subunits 2102.

FIGS. 75A and 75B illustrate another embodiment of a support frame 2200comprising an annular main body 2201 including a plurality ofleaflet-engaging mechanisms configured as frame subunits 2202. The framesubunits 2202 can be formed by a plurality of frame members 2204configured as retaining arms, similar to the embodiment of FIGS. 74A and74B. FIG. 75A is a side elevation view of a flattened layout pattern ofthe support frame 2200, while FIG. 75B illustrates the support frame2200 in a fully expanded configuration. The frame subunits 2202 cancomprise an actuator portion 2206 and a leaflet-engaging portion 2208.The leaflet-engaging portion 2208 can comprise two leaflet-clippingsubunits 2210, 2211 movable between an open position and a closedposition by actuation of the actuator portion 2206, similar to theembodiment of FIG. 71. In the embodiment shown, the frame 2200 includesthree frame subunits 2202, although the frame can include any suitablenumber of frame subunits depending upon the valve structure into whichthe frame is to be implanted.

Each of the frame members 2204 can comprise first and second branches2212, 2214, which can define the actuator portions 2206 of respectiveframe subunits 2202, as further described below. Each respective firstbranch 2212 can further divide into third and fourth branches 2216,2218, which can define respective boundaries of the leaflet-clippingsubunits 2210, 2211. Similarly, each respective second branch 2214 canfurther divide into fifth and sixth branches 2220, 2222.

Referring to the frame subunits 2202 generally, the actuator portion2206 can comprise a peak 2224 and two valleys 2226. The peak 2224 can beformed by the intersection of the first branch 2212 and the secondbranch 2214 of the frame member 2204 at a proximal end of the framemember 2204. The valleys 2226 can be defined by the fourth and fifthbranches 2218, 2220, and an interconnecting member 2228, which canextend between the fourth and fifth branches 2218, 2220. In theembodiment shown, the second branch 2214 can have an arcuate portion2232 extending laterally with respect to a longitudinal axis of thesupport frame 2200. In this manner, radial compression of the actuatorportion 2206, and particularly of the second branch 2214, can cause theleaflet-clipping subunits 2210, 2211 to move to the open position.

Referring to the leaflet-engaging portion 2208, the third and fourthbranches 2216, 2218 of the frame member 2204 can extend distally fromthe first branch 2212 to a distal end of the leaflet-engaging portion2208 where they can intersect the sixth and fifth branches 2222, 2220,respectively. In this manner, the third and sixth branches 2216, 2222 ofthe frame member 2204 can define a valley 2235 of the leaflet-clippingsubunit 2210, and the fourth and fifth branches 2218, 2220 can define avalley 2234 of the leaflet-clipping subunit 2211. The sixth branch 2222and the third branch 2216 can also be interconnected by aninterconnecting member 2229, similar to the interconnecting member 2228.The interconnecting members 2228, 2229 can comprise central peaks 2230,2231, respectively, and can be angled away from one another. In thismanner, the interconnecting members 2228, 2229 can act as springs,biasing the leaflet-clipping subunits 2210, 2211 toward the closedposition when the stent 2200 is in the fully expanded configuration. Inthis manner, the leaflet-clipping subunits 2210, 2211 can be configuredto engage and retain the native leaflets of a heart valve between therespective leaflet-clipping subunits when the frame is deployed in anative valve.

The support frame 2200 can be configured such that when partiallydeployed from the end of a catheter with the actuator portions 2206 ofthe respective frame subunits 2202 within the catheter and theleaflet-clipping subunits 2210, 2211 outside the catheter, radialcompression of the actuator portions 2206 can actuate or lever theleaflet-clipping subunits 2210, 2211 into the open position, similar tothe embodiment of FIG. 71. In this manner, a user can position thesupport frame over the commissures of the native valve leaflets suchthat the leaflets are located between respective leaflet-clippingsubunits 2210, 2211 of the leaflet-engaging portions 2208. As thesupport frame 2200 is more fully deployed, the radial compression of theactuator portions 2206 can be released, causing the leaflet-clippingsubunits 2210, 2211 to move to the closed position, capturing theleaflets of the native valve therebetween. Partially retracting thesupport frame 2200 back into the catheter can reopen theleaflet-clipping subunits 2210, 2211 by reapplying radial compression tothe actuator portions 2206, permitting the user to reposition thedevice.

FIGS. 76A and 76B illustrate another embodiment of a support frame 2300comprising an annular main body including a plurality ofleaflet-engaging mechanisms configured as frame subunits 2302. Theplurality of frame subunits 2302 can be formed by a corresponding numberof branching members 2304, similar to the embodiment of FIG. 71. Theframe subunits 2302 can comprise an actuator portion 2306 and aleaflet-engaging portion 2308. The leaflet-engaging portion 2308 cancomprise two leaflet-clipping subunits 2310 movable between an openposition (FIG. 76B) and a closed position (FIG. 76A) by actuation of theactuator portion 2306. In the embodiment shown, the frame 2300 includesthree frame subunits 2302 formed by three respective branching members2304, and interconnected by connecting members 2312.

Referring to the frame subunits 2302 generally, the actuator portion2306 can comprise a peak 2314 and a valley 2316. The peak 2314 can beformed by the intersection of a first branch 2318 and a second branch2320 of the branching member 2004 at a proximal end of the actuatorportion 2306. The first and second branches 2318, 2320 of the branchingmember 2304 can be angular, and can further branch into third and fourthbranches 2322, 2324, and fifth and sixth branches 2326, 2328,respectively. In the embodiment shown, the third, fourth, fifth, andsixth branches 2322, 2324, 2326, 2328 are thicker than the first andsecond branches 2318, 2320 from which they originate. In this manner,the first and second branches 2318, 2320 can be configured to deform toa greater degree than the leaflet-clipping subunits 2310 when the whenthe support frame is in the open configuration. However, in alternativeembodiments, all branches of the branching member 2304 can have the samethickness.

The valley 2316 can be defined by the convergence of the fourth andfifth branches 2324, 2326 of the branching member 2304 near a proximalend of the leaflet-engaging portion 2308, where the fourth and fifthbranches 2324, 2326 can be interconnected by a spring member 2334. Inthe embodiment shown, the fourth and fifth branches 2324, 2326 converge,but do not intersect to form a single integral member. However, inalternative embodiments, the fourth and fifth branches 2324, 2326 canintersect to form an integral member, as desired. In the embodimentshown, the peak 2314 can further comprise a retaining arm 2311.

The leaflet-clipping subunits 2310 can each have a peak 2330 and avalley 2332. The peaks 2330 can be formed by the respective proximalintersections of the third and fourth branches 2322, 2324, and the fifthand sixth branches 2326, 2328, respectively, of the branching member2302. Similarly, the valleys 2332 can be formed by the respective distalintersections of the third and fourth branches 2322, 2324, and the fifthand sixth branches 2326, 2328, respectively. The respective peaks 2330of the leaflet-clipping subunits 2310 can be angled away from oneanother such that the leaflet-clipping subunits are biased toward theclosed position when the frame is in the fully expanded configuration.In this manner, the leaflet-clipping subunits 2310 can be configured toengage and retain the native leaflets between the respectiveleaflet-clipping subunits 2310 when the frame 2300 is deployed in anative valve. As noted above, the fourth and fifth branches 2324, 2326can also be interconnected by a spring member 2334, which can aid inbiasing the leaflet-clipping subunits 2310 toward the closed position.

The support frame 2300 can be configured such that when partiallydeployed from the end of a catheter with the actuator portions 2306 ofthe respective frame subunits 2302 within the catheter and theleaflet-clipping subunits 2310 outside the catheter, radial compressionof the actuator portions 2306 can actuate or lever the leaflet-clippingsubunits 2310 into the open position (FIG. 76B), as described above withrespect to the embodiment of FIG. 71. In this manner, a user canposition the support frame 2300 over the commissures of the native valvesuch that the leaflets are located between respective leaflet-clippingsubunits 2310 of the leaflet-engaging portions 2308. As the supportframe 2300 is more fully deployed, the radial compression of theactuator portions 2306 can be released, causing the leaflet-clippingsubunits 2310 to close (FIG. 76A), capturing the leaflets of the nativevalve therebetween. Partially retracting the support frame back into thecatheter can reopen the leaflet-clipping subunits 2310 by reapplyingradial compression to the actuator portion 2306, permitting the user toreposition the device.

The branching members 2304 of the support frame can be laser cut (orotherwise machined or formed) from a single piece of material (e.g., atubular piece of metal) such that the frame subunits 2302 are integralto the support stent. In other embodiments, the various branches of thebranching members 2304 can be separately formed and welded or otherwisecoupled together to form the frame subunits 2302. In further alternativeembodiments, respective frame subunits can be integrally formed and thenjoined together by, for example, welding, brazing, adhesives, etc.

FIGS. 77A and 77B illustrate another embodiment of a support frame 2400comprising an annular main body 2401 (FIG. 77B) formed by a plurality ofstruts 2402, which can include a plurality of apices 2404 formed by theintersection of two adjacent struts 2402. The support frame can furtherinclude one or more leaflet-engaging mechanisms 2406 comprising firstand second pairs 2408, 2410 of struts 2402 extending distally fromrespective apices 2404. The struts 2402 of each respective pair 2408,2410 can be angled away from one another such that the pairs 2408, 2410of struts 2402 define a leaflet capture region 2412 therebetween. Thepairs 2408, 2410 of struts 2402 of each leaflet-engaging portion 2406can also be angled away from one another such that the leaflet captureregion 2412 defined therebetween narrows toward the proximal end of thesupport frame 2400 before terminating at the respective apices 2404.

For example, in the embodiment shown in FIGS. 77A and 77B, the firstpair 2408 of struts 2402 can be angled such that the struts 2402 extendradially inward from the respective apices 2404. Similarly, the secondpair 2410 of struts 2402 can be angled such that the struts 2402 extendradially outward from the respective apices 2404. In this manner, theleaflet-engaging portions 2406 can be slipped over the native leafletsof the aorta like paperclips. In some embodiments, the distal endportions of the struts 2402 of the first and second pairs 2408, 2410 caninclude surface treatments such as threads, grooves, surface roughness,etc., to aid in retaining the native leaflets 2414 after implantation.

In an alternative embodiment shown in FIG. 77C, the leaflet-engagingmechanisms 2406 can be oriented at right angles to the annular main body2401. In this manner, the leaflet-engaging mechanisms 2406 can beslipped over the commissures 2418 formed by the native leaflets 2414 ofthe aorta 2420. In this manner, the support frame 2400 can reduce thevalvular orifice area of the aorta 2420 by restricting the degree towhich the native leaflets 2414 are allowed to open.

FIGS. 78-89 illustrate another embodiment of a stent 2500 comprising anannular main body 2501 formed by a plurality of struts 2502. The stent2500 can include one or more active leaflet-engaging mechanisms 2504situated on three respective apices 2506 formed by the intersection oftwo adjacent struts 2502. The leaflet-engaging mechanisms 2504 cancomprise leaflet clips 2508 having two clipping arms 2510 slidablydisposed in an annular constraint 2512. The clipping arms 2510 of theleaflet clips 2508 can be movable between an open position (see, e.g.,FIG. 78) and a closed position (see, e.g., FIG. 89) as the leaflet clip2508 is drawn distally and proximally, respectively, through the annularconstraint 2512. In this manner, the leaflet-engaging mechanisms 2504can permit a user to position the support frame 2500 in a first step andclip the leaflets of a native valve in a second step, thereby providingimproved control on both positioning and clipping force. Theleaflet-engaging mechanisms 2504 can be disposed on the interior of thesupport frame 2500, as shown in FIG. 78, or on the exterior of thesupport frame, as shown in FIG. 79.

Referring to FIG. 80, the leaflet clips 2508 can comprise a proximalhairpin portion 2514 formed by parallel sections of the clipping arms2510, an intermediate portion 2516 in which the clipping arms 2510diverge, and a leaflet-engaging portion 2518 in which end portions 2520of the respective clipping arms 2510 are oriented toward one another. Insome embodiments, the hairpin portions 2514 of the leaflet clips 2508can extend above the respective apices 2506 of the stent such thatproximal movement of the leaflet clips 2508 through the annularconstraints 2512 can cause the annular constraints 2512 to apply forceto the clipping arms 2510. Application of force to the clipping arms2510 by the annular constraint 2512 can cause the end portions 2520 ofthe clipping arms 2510 to move toward one another. The distance betweenthe respective end portions 2520 of the clipping arms 2510, and theresultant force applied to the native leaflets therebetween, can becontrolled by appropriate vertical positioning of the leaflet clips 2508in the annular constraints 2512.

In some embodiments, the leaflet clips 2508 can be configured to matchthe geometric profile of the struts 2502 of the support frame 2500 suchthat the potential for the leaflet clips 2508 to interfere withpositioning of the stent is reduced. For example, the clipping arms 2510can define an angle θ between the hairpin portion 2514 and theintermediate portion 2516. The angle θ can be configured such that thediverging portions of the clipping arms 2510 approximate the profile ofthe struts 2502 of the support frame 2500. Similarly, the end portions2520 of the clipping arms 2510 can be oriented at an angle α with thediverging portions of the clipping arms 2510 of the intermediate portion2516. The end portions 2520 of the clipping arms 2510 can also have alength L. The angle α and the length L of the end portions 2520 can beselected to reduce the tendency of the leaflet clips 2508 to interferewith placement of the stent 2500 during implantation, while allowing theend portions 2520 to engage and retain the native leaflets. In someembodiments, the angle θ can be from about 130 degrees to about 170degrees. In some embodiments, the angle θ can be about 147 degrees. Insome embodiments, the angle α can be from about 45 degrees to about 60degrees.

In some embodiments, the clipping arms 2510 of the leaflet clips 2508can have a rectangular cross-sectional shape. This can increase thetorsional stiffness of the clipping arms 2510, reducing the tendency ofthe end portions 2520 to rotate inwardly or outwardly when the clippingarms are forced together by the annular constraint 2512. In alternativeembodiments, the clipping arms 2510 can have a round cross-sectionalshape, or any other suitable cross-sectional shape.

The annular constraints 2512 can be configured as, for example, tubularmembers, suture loops, or folding tabs. In the embodiment shown, theannular constraints 2512 are configured as suture loops encircling eachrespective apex 2506 to which a leaflet-engaging mechanism 2504 ismounted. The annular constraints 2506 can also be configured as one ormore suture loops that encircle each strut 2502 below the apex 2506 towhich a leaflet-engaging mechanism 2504 is mounted. The annularconstraints 2512 can be integral to the support frame 2500, or can beseparately attached.

FIG. 81 illustrates a portion of an actuation assembly 2534 of adeployment device 2522 (FIG. 83) for actuating the leaflet-engagingmechanisms 2504. The actuation assembly 2534 can comprise an actuatormember catheter 2524 dimensioned to receive the proximal hairpin portion2514 of a leaflet clip 2508, and an actuator member 2526 slidablydisposed in the actuator member catheter 2524. A distal end portion 2528of the actuator member 2526 can comprise a tab 2530 including a pin2532. The pin 2532 can be dimensioned to engage the proximal end of thehairpin portion 2514, as shown in FIG. 82A. The actuator member catheter2524 can then be moved over the distal end portion 2528 of the actuatormember 2526 and the engaged hairpin portion 2514 in the direction ofarrow 2548, thereby securing the leaflet clip 2508 to the actuatormember 2526, as shown in FIG. 82B. In this manner, longitudinal movementof the actuator member 2526 in the actuator member catheter 2524 cancause corresponding movement of the leaflet clip 2508 through theannular constraint 2512. This, in turn, can cause the clipping arms 2510of the leaflet clip 2508 to move between the open and closed positions.The leaflet clip 2508 can be released by retracting the actuator membercatheter 2524, exposing the distal end portion 2528 of the actuatormember 2526 and allowing the hairpin portion 2514 to disengage from thepin 2532. The deployment device 2522 can comprise a correspondingactuation assembly 2534 for each leaflet-clipping mechanism 2504 of thesupport frame 2500, as shown in FIG. 83.

FIGS. 84 and 85 illustrate alternative embodiments of the distal endportions 2528 of the actuator members 2526. FIG. 84 shows distal endportions 2528 of the actuator member 2526 comprising hooks 2536configured to engage the hairpin portions 2514 of the leaflet clips2508. The actuator member of FIG. 84 can be used in conjunction with theframe of FIG. 86, which includes integral tabs 2540 extending fromrespective apices 2506 and located radially inward of theleaflet-clipping mechanisms 2504. FIG. 85 shows another embodiment of adistal end portion 2528 of the actuator member 2526 having a circularprotrusion 2538 located toward a proximal end of the tab 2530. The roundshape of the protrusion 2538, along with its location toward theproximal end of the tab 2530 can reduce the tendency of the leafletclips 2508 to prematurely disengage from the actuator member 2526.

FIG. 87 is a perspective view of the deployment device 2522 coupled tothe support frame 2500. The deployment device can comprise an outersheath 2550. The actuator member catheters 2524 and associated actuatormembers 2526 can engage the respective leaflet clipping mechanisms 2504,and can pass through the outer sheath 2550. Similarly,retaining-arm-engaging members 2552 can pass through the outer sheath2550 and can engage the respective retaining arms 2556 of the supportframe. In this manner, the various actuator member catheters 2524,actuator members 2525, retaining-arm-engaging members 2552, andretaining member catheters 2556 can be actuated independently of oneanother. FIG. 88 illustrates the support frame 2500 engaged to thedeployment device 2522 with the actuator members 2526 retracted and theleaflet clips 2508 of the leaflet-clipping mechanisms 2504 in the closedposition.

FIGS. 89A and 89B illustrate perspective views of one embodiment of anouter sheath 2540 for use with the support frame 2500. The outer sheath2540 can comprise an outer proximal catheter 2542, and three distalcatheters 2544 extending from and in communication with the outerproximal catheter 2542. The outer sheath 2540 can further comprise aninner proximal catheter 2546, shown in FIG. 88B, which can configured tobe contained within the outer proximal catheter 2542. The actuatormembers 2526 of the respective actuator assemblies 2534 can beconfigured to travel in the lumens of the respective distal catheters2544.

The following description concerns various embodiments of support framesthat are configured to be self-retaining in the native valve throughapplication of pressure to various anatomical structures of the nativevalve, such as via one or more frame-retaining mechanisms configured toengage portions of the aortic root and/or the aorta. Any of theembodiments described herein having leaflet-engaging mechanisms can beprovided with one or more frame-retaining mechanisms described in detailbelow, unless the context suggests otherwise. Similarly, any of theembodiments described herein having one or more frame-retainingmechanisms can be provided with one or more leaflet-engaging mechanisms,unless the context suggests otherwise.

The following embodiments can be used for treating valve insufficiencyby, for example, reducing the valvular circumference or reducing thevalvular orifice area. The following embodiments can also be used forsupporting a transcatheter heart valve (THV), and can be used incombination with any of the support frames described herein. Referringto FIG. 90, a support frame or stent 2600 can comprise an annular mainbody 2601 formed by a plurality of angled struts 2602. The support stent2600 can include one or more retaining arms 2604 (e.g., three equallyspaced retaining arms 2604) extending proximally from the apices 2606 ofthe struts 2602. The retaining arms 2604 can be used to form areleasable connection with the distal end of a delivery apparatus, aspreviously described. In some embodiments, the support stent 2600 caninclude one or more projections or protrusions (not shown) that canassist in retaining a THV in the implanted position within the interiorof the support stent 2600, as further described in U.S. PatentApplication No. 61/729,109 and WIPO Publication No. 2014/081796, whichare incorporated herein by reference.

FIGS. 91 and 92 show another embodiment of a support frame 2700comprising an annular main body formed by a plurality of angled struts2702, similar to the embodiment of FIG. 90. FIG. 91 shows the supportframe 2700 located in a partial cross-section of an aorta 2704. Thesupport frame 2700 can further comprise one or more frame-retainingmechanisms configured as arcuate members 2706. The arcuate members canbe configured to extend radially outwardly from the support frame andcontact the walls of the aortic root 2708. For purposes of illustration,the front half of the support frame is not shown. FIG. 92 is across-sectional plan view of the support frame 2700 located in the aorta2704.

The arcuate members 2706 can comprise metal or polymer strips or hoops.In the embodiment shown, the arcuate members 2706 can contact the wallsof the aortic root 2708 from substantially the aortic valve 2710 tosubstantially the sinotubular junction 2712. In this manner, the arcuatemembers 2706 can retain the support frame 2700 in place afterimplantation. In alternative embodiments, the height of the arcuatemembers 2706 can be configured such that the arcuate members 2708contact any suitable portion of the walls of the aortic root 2708.

FIGS. 93-96 show various embodiments of another support frame 2800located in a partial cross-section of the aorta 2802. The support stent2800 can comprise an annular main body formed by a plurality of angledstruts 2804 similar to the embodiment of FIG. 90 above. The supportstent 2800 can further include one or more elongated frame-retainingmechanisms configured as vertical members 2806 extending proximally fromapices 2808 formed by the intersection of respective adjacent struts2804. The one or more vertical members 2806, in turn, can comprise oneor more elongated horizontal members 2810 configured to contact thewalls of the ascending aorta 2812, thereby retaining the support stent2800 in place after implantation.

In some embodiments, the vertical members 2806 can be shape set suchthat they are biased against the walls of the ascending aorta 2812 whenthe support stent 2800 is expanded to its fully expanded configuration.Similarly, the one or more horizontal members 2810 can be shape set tohave a radius larger than the radius of the ascending aorta 2812 suchthat the horizontal members 2810 are biased against the walls of theascending aorta 2812 when the support stent is fully expanded. Thevertical and horizontal members 2806, 2810 can thereby work in concertto retain the support frame 2800 in position after implantation. Thevertical and horizontal members 2806, 2810 can be fabricated fromsuitable shape-memory metals or alloys, such as spring steel,cobalt-chromium alloy (Elgiloy®), or nitinol, or from various polymericmaterials.

The number, size, and position of the vertical and horizontal members2806, 2810 can vary from implementation to implementation. For example,as shown in FIG. 93, the support stent 2800 can include vertical members2806 extending from each apex 2808 and horizontal members 2810 locatedat intervals along the length of the vertical members 2806. Thehorizontal members 2810 can be further configured to extend aroundsubstantially the entire circumference of the ascending aorta 2812. Insome embodiments, the horizontal members 2810 can be coupled to each ofthe vertical members 2806. Alternatively, the horizontal members 2810can be coupled to a single vertical member 2806, or any other suitablenumber of vertical members 2806.

In further alternative embodiments, the horizontal members 2810 canextend around less than the entire circumference of the ascending aorta2812, and can be vertically offset from one another, as shown in FIGS.94 and 96. More specifically, as shown in FIG. 94, each of thehorizontal members 2810 can be centered about a single vertical member2806, and can extend around the two adjacent vertical members 2806without extending around the entire circumference of the ascending aorta2812. Alternatively, each of the horizontal members 2810 can be centeredabout a single vertical member 2806 without extending around theadjacent vertical members, as shown in FIG. 96.

In another alternative embodiment shown in FIG. 95, the support stent2800 can comprise a frame-retaining mechanism configured as a singlevertical member 2806 extending from a single apex 2808. The verticalmember 2806 can further include one or more horizontal members 2810centered about and coupled to the vertical member 2806. The horizontalmembers 2810 can be configured to extend around substantially the entirecircumference of the ascending aorta 2812, or any portion thereof, asdesired. The vertical and horizontal members 2806, 2810 can be shape setor otherwise configured to contact the walls of the ascending aorta 2812to retain the support frame 2800 in position after implantation, asdescribed above. The vertical and horizontal members 2806, 2810 can beintegrally formed with the support frame 2800, or can be separatelyformed and secured to the support frame and/or to one another by, forexample, welding, brazing, suture, adhesives, etc.

Referring now to FIG. 97, there is shown another embodiment of a supportframe 2900 comprising an annular main body formed by a plurality ofangled struts 2902 and having a plurality of apices 2904 formed by theintersection of two adjacent struts 2902, similar to the embodiment ofFIG. 90 above. The support frame 2900 is shown located in a partialcross-section of an aorta 2906. The support frame 2900 can furthercomprise frame-retaining mechanism configured as an annular member 2908coupled to the support frame 2900 by one or more rigid, or semi-rigid,vertical members 2910 extending from respective apices 2904. The annularmember 2908 can be located in the aortic root 2912 and can be configuredto contact the walls of the aortic root 2912 substantially beneath thesinotubular junction 2914. In this manner, the annular member 2908 incombination with the one or more vertical members 2910 can restrainupward movement of the support frame 2900 in the aortic root 2912.

In the embodiment shown, the support frame 2900 can comprise twovertical members 2910 on the portion of the support frame located in thedorsal half of the aorta 2906, and two vertical members 2910 on theportion of the support frame located in the ventral half of the aorta2906 (not shown). However, in alternative embodiments, the support frame2900 can include any suitable number of vertical members 2910 located onany suitable portion of the support frame 2900. The vertical members2910 can be integrally formed with the support frame 2900, or can beseparately formed and secured to the support frame by, for example,welding, brazing, suture, adhesives, etc.

FIG. 98 shows another embodiment of a support frame 3000 comprising anannular main body formed by a plurality of angled struts 3002 similar tothe embodiment of FIG. 90 above. The support frame 3000 is shown locatedin a partial cross-section of an aorta 3004. The support frame 3000 canhave a plurality of proximal apices 3006 and distal apices 3008 formedby the intersections of two adjacent struts 3002 at respective proximaland distal ends of the support frame. The struts 3002 can thereby definea height H extending from the proximal apices 3006 to the distal apices3008. The struts 3002 can also be configured to conform to the contoursof the aortic root 3010 such that the struts contact the walls of theaortic root 3010. For example, the support frame 3000 can be shape setto have a diameter greater than the diameter of the aortic root 3010,causing the struts 3002 to contact the walls of the aortic root 3010 toretain the support stent in place after implantation.

In the embodiment shown, the height H can be configured such that theproximal apices 3004 are located adjacent the sinotubular junction 3012and the distal apices 3008 are located adjacent the aortic valve 3014.In this manner, the struts 3002 can operate as a frame-retainingmechanism by contacting and exerting force against the walls of theaortic root 3010 along substantially the entire length of the aorticroot 3010 from adjacent the sinotubular junction 3014 to adjacent theaortic valve leaflets 3014. Alternatively, the height H can beconfigured such that the struts 3002 contact any suitable portion of thewalls of the aortic root 3010. In further alternative embodiments, theproximal apices 3006 can be configured to contact the sinotubularjunction 3012 and the distal apices 3008 can be configured to contactthe aortic valve leaflets 3014.

FIGS. 99A, 99B, and 100 illustrate another embodiment of a support frame3100 comprising an annular main 3101 body formed by a plurality ofangled struts 3102, similar to the embodiment of FIG. 90 above. Thesupport frame 3100 can have a plurality of proximal apices 3104 anddistal apices 3106 formed by the intersections of two adjacent struts3102 at respective proximal and distal ends of the support frame. In theembodiment shown, the proximal apices 3104 can comprise retaining arms3118 extending proximally therefrom. The support frame 3100 can furthercomprise a plurality of frame-retaining mechanisms configured as arcuatemembers 3108. The arcuate members 3108 can extend distally fromrespective distal apices 3106 before curving radially outward and endingat rounded distal end portions 3110. In the embodiment shown, the distalend portions 3110 can be oriented generally proximally with respect tothe support frame 3100. Referring to FIG. 100, when implanted in theaorta 3112, the arcuate members 3108 can be configured to contact andapply pressure to the walls of the aortic root 3114, thereby retainingthe support frame 3100 in place after implantation. In some embodiments,the arcuate members 3108 can also be configured to contact the bases ofthe aortic valve leaflets 3116, as shown in FIG. 100. The arcuatemembers 3108 can be integrally formed with the support frame 3100, orcan be separately formed and secured to the support frame 3100 by, forexample, welding, brazing, suture, adhesives, etc.

FIG. 101 illustrates another embodiment of a support frame 3200comprising an annular main body formed by a plurality of angled struts3202. The support frame 3200 is shown located in a partial cross-sectionof an aorta 3204, and can further comprise a plurality of apices 3206formed by the intersection of two adjacent struts 3202. The supportframe can include one or more frame-retaining mechanisms configured asretaining arms 3208 extending proximally from the apices 3206. Theretaining arms 3208 can be configured to contact and exert pressureagainst the walls of the aortic root 3210 and/or the sinotubularjunction 3212, thereby urging the support frame 3200 downward and aidingin retaining the support frame in place after implantation. In theembodiment shown, the retaining arms 3208 can be flexible such that theydeflect radially inward upon contacting the walls of the aortic root3210 and/or the sinotubular junction 3212. The retaining arms 3208 canbe made from metal (e.g., nitinol) or suitable biocompatible polymers,and can be integrally formed with the support frame 3200 or separatelyformed and secured to the support frame by, for example, welding,brazing, suture, adhesives, etc.

FIG. 102 illustrates another embodiment of a support frame 3300comprising an annular main body formed by a plurality of angled struts3302. The support frame 3300 is shown located in a partial cross-sectionof an aorta 3304, and can further comprise a plurality of apices 3306formed by the intersection of two adjacent struts 3302. The supportframe 3300 can further comprise a frame-retaining mechanism configuredas a spring member 3308 extending proximally from an apex 3306 of thesupport frame 2300 into the ascending aorta 3310. The spring member 3308can be helically wound or coiled, and can be shape set to have adiameter greater than the ascending aorta 3310 such that the springmember 3308 contacts and exerts a force against the walls of theascending aorta 3310. This, in turn, can urge the support frame 3300downward, helping to retain the support frame in place afterimplantation. In the embodiment shown, the spring member 3308 canoriginate from a single apex 3306. However, in alternative embodiments,the spring member 3308 can originate from any suitable number of apices3306, including all of the apices 3306. In some embodiments, the springmember 3308 can be configured as a retaining arm, which can engage witha delivery device 3312, as shown in FIG. 103. The spring member 3308 canbe made from metal (e.g., nitinol) or suitable biocompatible polymers,and can be integrally formed with the support frame 3300 or separatelyformed and secured to the support frame by, for example, welding,brazing, suture, adhesives, etc.

FIG. 104 illustrates another embodiment of a support frame 3400 locatedin a partial cross-section of an aorta 3402. The support frame 3400 cancomprise a first annular frame 3404 formed by a plurality of angledstruts 3406, and a second annular frame 3408 formed by a plurality ofangled struts 3410. The first annular frame 3404 can be situated in theaortic root 3412 proximate the aortic valve leaflets 3414, while thesecond annular frame 3408 can be situated in the ascending aorta 3416proximate the sinotubular junction 3418. In some embodiments, the secondannular frame 3408 can be configured to have a diameter greater than thediameter of the ascending aorta 3416 such that the second annular frame3408 exerts a radial force against the walls of the ascending aorta3416. This can allow the second annular frame 3408 to resist proximaland/or distal motion within the ascending aorta 3416.

The first and second annular frames 3404, 3408 can be interconnected byone or more frame-retaining mechanisms configured as interconnectingmembers 3420. The one or more interconnecting members 3420 can becoupled to proximal apices 3422 of the first annular frame 3404 and todistal apices 3424 of the second annular frame 3408, and can bespring-biased. In this manner, the interconnecting members 3420 can urgethe first annular frame 3404 downwardly, thereby helping to retain thesupport frame 3400 in place after implantation. In the embodiment shown,the interconnecting members 3420 can be configured to deflect andcontact the walls of the aortic root and/or the sinotubular junction3418, further increasing the stability of the support frame 3400 afterimplantation. In some embodiments, the interconnecting members 3420 canbe made from metal (e.g., nitinol) or suitable biocompatible polymers,and can be integrally formed with the first and second annular frames3404, 3408. Alternatively, the interconnecting members 3420 and thefirst and second annular frames 3404, 3408 can be separately formed andsecured together by, for example, welding, brazing, suture, adhesives,etc.

FIG. 105 illustrates another embodiment of a support frame 3500 locatedin a partial cross-section of an aorta 3502. The support frame 3500 cancomprise a first annular frame 3504 formed by a plurality of angledstruts 3506, and a second annular frame 3508 formed by a plurality ofangled struts 3510, similar to the embodiment of FIG. 104. The firstannular frame 3504 can be situated in the aortic root 3512 proximate theaortic valve leaflets 3514, while the second annular frame 3508 can besituated in the ascending aorta 3516 proximate the sinotubular junction3518. In some embodiments, the second annular frame 3508 can beconfigured to have a diameter greater than the diameter of the ascendingaorta 3516 such that the second annular frame 3508 exerts a radial forceagainst the walls of the ascending aorta 3502. This can allow the secondannular frame 3508 to resist proximal and/or distal motion within theascending aorta 3516.

The first and second annular frames 3504, 3508 can be interconnected bya frame-retaining mechanism configured as a spring member 3520. Thespring member 3520 can be coupled to a respective proximal apex 3522 ofthe first annular frame 3504 and to a respective distal apex 3524 of thesecond annular frame 3508, and can be helically coiled. In this manner,the spring member 3520 can urge the first annular frame 3504 downwardly,thereby helping to retain the support frame 3500 in place afterimplantation. In the embodiment shown, the spring member 3520 is coupledto a single proximal apex 3522 of the first annular frame 3504 and asingle distal apex 3524 of the second annular frame 3508. Alternatively,the spring member 3520 can be coupled to multiple proximal apices 3522and/or multiple distal apices 3524 of the first and second annularframes 3504, 3508, respectively. In further alternative embodiments, thesupport frame 3500 can comprise multiple spring members 3520. In someembodiments, the spring member 3520 can be made from metal (e.g.,nitinol) or suitable biocompatible polymers, and can be integrallyformed with the first and second annular frames 3504, 3508.Alternatively, the spring member 3520 and the first and second annularframes 3504, 3508 can be separately formed and secured together by, forexample, welding, brazing, suture, adhesives, etc.

FIGS. 106-108 illustrate another embodiment of a support frame 3600comprising a first annular frame 3602 formed by a plurality of angledstruts 3604, and a second annular frame 3606 comprising a plurality offrame subunits 3608 formed by a corresponding number of branchingmembers 3610. The first annular frame 3602 can be configured to belocated in the aortic root, while the second annular frame 3606 can beconfigured to be located in the ascending aorta, similar to theembodiments of FIGS. 104 and 105. The frame subunits 3608 of the secondannular frame 3606 can comprise proximal apices 3612 formed by theproximal intersection of two respective branching members 3610 anddistal apices 3614 formed by corresponding distal intersections of thebranching members 3610. In the embodiment shown, alternating proximalapices 3612 can comprise retaining arms 3616 extending therefrom. Thesecond annular frame 3606 can be configured to have a diameter greaterthan the diameter of the ascending aorta such that the second annularframe 3608 exerts a radial force against the walls of the ascendingaorta. This can allow the second annular frame 3606 to resist proximaland/or distal motion within the ascending aorta. The frame subunits 3608can be optionally coupled by short coupling members 3622, which canincrease the rigidity of the second frame 3606.

The first and second annular frames 3602, 3606 can be interconnected byone or more frame-retaining mechanisms configured as interconnectingmembers 3618. The one or more interconnecting members 3618 can becoupled to respective proximal apices 3620 of the first annular frame3602 and to respective distal apices 3614 of the second annular frame3606, and can be helically coiled. In this manner, the interconnectingmembers 3618 can urge the first annular frame 3602 downwardly, therebyhelping to retain the support frame 3600 in place after implantation. Inthe embodiment shown, an interconnecting member 3618 interconnects eachproximal apex 3620 of the first annular frame 3602 with each distal apex3614 of the second annular frame 3606. Alternatively, interconnectingmembers 3618 can interconnect every other proximal apex 3620 of thefirst annular frame 3602 with every other distal apex 3614 of the secondannular frame 3606. In further alternative embodiments, each proximalapex 3620 of the first annular frame 3602 can be interconnected witheach distal apex 3614 of the second annular frame 3606 by pairs ofinterconnecting members 3618, as shown in FIG. 108. In the embodiment ofFIG. 108, the interconnecting members 3618 of each respective pair canextend in opposite radial directions around the support frame 3600 fromthe respective proximal apices 3620 of the first annular frame 3602 tothe distal apices 3614 of the second annular frame (i.e., oneinterconnecting member 3618 can extend in a clockwise direction whilethe other interconnecting member can extend in a counterclockwisedirection before coupling to the respective distal apex 3614 of thesecond frame 3606). Additionally, in some embodiments the support frame3600, and particularly the second frame 3608, can be configured to beaxially compliant such that the geometry of the support frame 3600 canchange to accommodate variations in the shape of the ascending aorta.

FIGS. 109-112 illustrate another embodiment of a support frame 3700comprising an annular main body 3701 formed by a plurality of angledstruts 3702 and having a plurality of apices 3704 formed by theintersection of two adjacent struts 3702. In FIGS. 110 and 112, thesupport frame 3700 is shown located in a partial cross-section of anaorta 3706. The support frame 3700 can further comprise aframe-retaining mechanism configured as a semi-annular member 3708coupled to the support frame 3700 by two rigid, or semi-rigid, verticalmembers 3710 extending from respective apices 3704, similar to theembodiment of FIG. 97. The support frame 3700 can be located in theaortic root 3712, while the semi-annular member 3708 can be located inthe ascending aorta 3714, as shown in FIGS. 110 and 112.

In the embodiment shown, the vertical members 3710 can be integral withthe semi-annular member 3708, and can be shape set such that thesemi-annular member 3708 has a diameter greater than the ascending aorta3714. In this manner, the semi-annular member 3708 can be configured toexert radial force against the walls of the ascending aorta 3714 which,in combination with the two vertical members 3710, can restrain upwardmovement of the support frame 3700 in the aortic root 3712. For example,in the embodiment of FIG. 109, the vertical members 3710 can be shapeset such that they extend away from one another at an angle in theproximal direction, thereby urging the semi-annular member 3708 radiallyoutward. In this manner, the semi-annular member 3708 can have adiameter greater than the diameter of the ascending aorta 3714 when thesupport frame is in the fully expanded configuration. Alternatively, thevertical members 3710 can be shape set such that they are orientedsubstantially parallel to a longitudinal axis of the support frame 3700when the support frame is in the expanded configuration, and thesemi-annular member 3708 can be configured to have a diameter greaterthan the diameter of the ascending aorta 3714 without urging by thevertical members 3710, as shown in FIG. 111. In this manner, thevertical members 3710 can be urged toward one another by radialcompression of the semi-annular member 3708 imposed by the walls of theascending aorta 3714, as shown in FIGS. 110 and 112, respectively, whichcan aid in retaining the support frame 3700 in place after implantation.

The vertical members 3710 and the semi-annular member 3708 can be madefrom metal (e.g., nitinol) or from suitable biocompatible polymers, andcan be integrally formed with the support frame 3700. Alternatively, thevertical members 3710 and the semi-annular member 3708 can be separatelyformed and secured to the support frame 3700 by, for example, welding,brazing, suture, adhesives, etc.

FIGS. 113-115 illustrate another embodiment of a support frame 3800comprising an annular main body 3801 formed by a plurality of angledstruts 3802 and having a plurality of apices 3804 formed by theintersection of two adjacent struts 3802. The support frame 3800 caninclude a plurality of frame retaining members 3806 configured asretaining loops 3808. The retaining loops 3808 can be located in theaortic root 3818 behind the native leaflets 3820 (see, e.g., FIGS. 117and 118), and can be configured to exert radial force against the wallsof the aortic root 3818 to aid in retaining the support frame 3800 inplace after implantation.

Each retaining member 3806 can comprise a proximal portion 3810 and adistal portion 3812. The proximal portion 3810 can be formed byrespective end portions 3814 of loop or wire 3808, which can extendproximally from respective apices 3804, before curving distally. In thismanner, the proximal portion 3810 can define a leaflet-engaging region3822 configured to receive the native leaflets 3820, and the respectiveend portions 3814 of the loops 3808 can extend over the native valveleaflets 3820 when the support frame is implanted (see, e.g., FIGS. 117and 118). The distal portion 3812 of the retaining member 3806 can bedefined by an intermediate portion 3816 of the loop or wire 3808, andcan have a radiused profile to distribute force against the walls of theaortic root 3818 (e.g., during the period of maximum pressuredifferential during the cardiac cycle).

In some embodiments, the loop or wire 3808 can extend proximally fromthe apices 3804 of the support frame 3800 for a distance of from about 5mm to about 10 mm before curving distally. In some embodiments, thedistal portions 3812 of the retaining members 3806 can have a height offrom about 12 mm to about 18 mm. In this manner, the height of theretaining members 3806 can be approximately equal to the height of thenative valve leaflets 3820, which can reduce the likelihood of damage tothe leaflets 3820 during and after implantation.

Referring to FIGS. 114 and 115, the support frame 3800 can be radiallycollapsible such that it can be loaded onto a delivery apparatus 3824 inthe direction of arrows 3832 via a loading device such as the funnelloader 3826, shown in phantom in FIG. 114. Alternatively, the supportframe 3800 can be loaded on to the delivery device 3824 with any ofvarious other loading devices, including reverse crimpers and circularspreaders. In some embodiments, the support frame 3800 can be radiallycollapsed around a transcatheter heart valve (“THV”) 3828, which canitself be radially collapsed around a balloon catheter 3830. The THV3828 can have a balloon-expandable metal frame supporting a valvemember, such as multiple tissue leaflets supported by the frame.

As shown in FIG. 115, the support frame 3800 can be held in place by anexternal sheath 3834. Retracting the external sheath 3834 can allow theretaining loops 3808 to expand radially into the aortic root 3818 behindthe native valve leaflets 3820, as shown in FIGS. 117 and 118. With theretaining loops 3808 in place behind the leaflets 3820, the ballooncatheter 3830 can be inflated, thereby radially expanding the THV 3828into its fully expanded configuration, and capturing the leaflets 3820between the THV 3828 and the support frame 3800, as shown in FIG. 119.With the THV 3828 anchored in place, the balloon catheter 3830 can bedeflated, and the delivery device 3824 can be retracted, leaving thesupport frame 3800 and the THV 3828 implanted in the aortic root 3818,as shown in FIG. 120.

The support frame 3800 can be configured such that as the THV 3828 andthe support frame 3800 are radially expanded by the balloon catheter3830, the support frame 3800 exerts a constant or nearly constant radialforce on the THV 3828. For example, as shown in the stress-strain plotof FIG. 116, the THV 3828 can be configured to have a diameter of about6 mm when radially collapsed around the delivery device 3824, and adiameter of about 30 mm when fully expanded. The support frame 3800,which can be collapsed onto the delivery device 3824 over the THV 3828,can have corresponding diameters when radially collapsed and expanded.As the support frame 3800 and the THV 3828 are expanded from theradially collapsed state to the fully expanded state, the radial forceexerted on the THV 3828 by the support frame 3800 can remain constant orincrease only slightly. This is illustrated by the area 3836 between thecurves 3838 and 3840 of FIG. 116, indicating that the support frame 3800absorbs a nearly constant amount of strain energy as the support frameand THV 3828 are expanded. In this manner, the rate and degree ofexpansion of the THV 3828 with the balloon catheter 3830 can beprecisely controlled. In alternative embodiments, any of the supportframes/stents described herein can be implanted with a THV using thedelivery apparatus 3824 and the delivery technique described above.

In an alternative embodiment shown in FIG. 121, the retaining loops 3808can comprise planar members 3840 coupled to and suspended from a pair ofcoupling members 3842. The coupling members 3842 can extend proximallyfrom respective apices 3804 before curving distally and coupling to theplanar members 3840, thereby defining leaflet-engaging regions 3844similar to the leaflet-engaging regions 3822. In some embodiments, theplanar members 3840 can comprise thin sheets of material (e.g., metalssuch as nitinol, polymeric materials, etc.), and can have a radiusedprofile. In some embodiments, the planar members 3840 and/or thecoupling members 3842 can be covered in a cloth material to cushion theload applied to the walls of the aortic sinuses 3818 and to promoteingrowth of the surrounding tissue. In further alternative embodiments,the delivery device 3824 need not include a THV 3828. Rather, thesupport frame 3800 can be implanted in the aorta and positioned so as toreshape the leaflets 3820 to address, for example, aortic insufficiency.

FIGS. 122-126 illustrate another embodiment of a support frame 3900comprising an annular main body 3901 formed by a plurality of first andsecond struts 3902, 3904. Respective pairs of first struts 3902 canintersect at first proximal apices 3906 and define leaflet-engagingmechanisms 3908. Similarly, respective pairs of second struts 3904 canintersect at second proximal apices 3910, thereby defining actuatormechanisms 3912. The leaflet-engaging mechanisms 3908 can be movablebetween an open position (FIG. 124) and a closed position (FIG. 125) byaction of a delivery device 3914, the relevant portion of which is shownin FIGS. 124-126.

The delivery device 3914 can comprise a plurality of first and secondactuator members 3922, 3924 configured to engage the first and secondapices 3906, 3910 of the leaflet-engaging mechanisms 3908 and theactuator mechanisms 3912, respectively. The first actuator members 3922can be configured to apply compressive axial force to the first apices3906 of the leaflet-engaging mechanisms 3908 in the direction indicatedby arrows 3928 (i.e., the first actuator members 3922 can be configuredto push downwardly on the first apices 3906 of the leaflet-engagingmechanisms 3908). Meanwhile, the second actuator members 3924 can beconfigured to apply tensile force to the second apices 3910 of theactuator mechanisms 3912 in the direction indicated by arrows 3930(i.e., the second actuator members 3924 can be configured to pullupwardly on the second apices 3910 of the actuator mechanisms 3912). Inthis manner, the combined action of the first and second actuatormembers 3922, 3924 can cause the second struts 3904 of the actuatormechanisms 3912 to be drawn together while the first struts 3902 of therespective leaflet-engaging mechanisms 3908 are drawn apart, therebymoving the leaflet-engaging mechanisms 3908 into the open position, asshown in FIG. 124. When the respective compressive and tensile forcesapplied to the leaflet-engaging mechanisms 3908 and actuator mechanisms3912 are released, the leaflet-engaging mechanisms 3908 can return tothe closed position (FIG. 125). In this manner, the leaflet-engagingmechanisms 3908 can engage and retain native valve leaflets 3944 whenthe support frame 3900 is implanted in the aorta 3946, as shown in FIG.126.

FIG. 123 illustrates a detail view of a representative leaflet-engagingmechanism 3908. Each leaflet-engaging mechanism 3908 can comprise aproximal portion 3916, a spring portion 3918, and a leaflet-engagingportion 3920. The proximal portion 3916 can include an aperture 3926configured to engage a respective first actuator member 3922 of thedelivery device 3914 (FIG. 124). The spring portion 3918 can comprisetwo spring subunits 3932, one spring subunit 3932 being located on eachrespective first strut 3902 of the leaflet-engaging mechanism 3908. Eachspring subunit 3932 can comprise a spring member 3934 and a pair oftravel-limiting members 3936. Each respective pair of travel-limitingmembers 3936 can define a gap 3938 therebetween. As axial force isapplied to the leaflet-engaging mechanism 3908 and tensile force isapplied to the adjacent actuator mechanisms 3912 by respective first andsecond actuator members 3922, 3924 of the delivery device 3914, thestruts 3902 can be drawn apart in the direction of arrows 3948. This canbias the spring members 3934 away from one another. Meanwhile, therespective travel-limiting members 3936 of each pair can be drawntogether until the travel-limiting members 3936 make contact, therebylimiting further travel of the spring members 3934 and, consequently, ofthe first struts 3902.

The leaflet-engaging portion 3920 of the leaflet-engaging mechanism 3908can define a leaflet-engaging region 3940 between the respective firststruts 3902 configured to receive the native leaflets 3944. In someembodiments, the leaflet-engaging region 3940 can extend between therespective spring members 3934 of the spring subunits 3932. In theembodiment shown, the opposing surfaces of the first struts 3902 of theleaflet-engaging portion 3920 can comprise barbs 3942 configured toengage and retain the native leaflets. In alternative embodiments, theopposing surfaces of the first struts 3902 of the leaflet-engagingportion 3920 can comprise any suitable surface treatment such asprojections, cutouts, surface roughness, etc., as desired. In someembodiments, the first and second struts 3902, 3904 can be integrallyformed with the support frame 3900. Alternatively, the first and secondstruts 3902, 3904 can be separately formed and secured together by, forexample, welding, brazing, suture, adhesives, etc.

FIGS. 127-129 illustrate another embodiment of a support frame 4000comprising an annular main body formed by a plurality of curved innerand outer members 4002, 4004, the inner and outer members intersectingat three respective apices or crowns 4006. The support frame 4000 can beconfigured to have a diameter less than the diameter of a regurgitantnative valve such that when implanted, the support frame 4000 can reducethe valve circumference and, thereby, the valvular orifice area. Thus,the support frame 4000 can effectively “re-model” the structure of theregurgitant valve at the base of the leaflets. In some embodiments, thesupport frame 4000 can pull together the commissures of the nativevalve, thereby improving leaflet coaptation (improving valve function).The support frame 4000 can also provide a restraint against furtherprogression of valve dilatation.

The inner members 4002 can be arranged to form an inner clover 4008having three inner apices 4010 formed by the intersection of adjacentinner members 4002. The outer members 4004 can be arranged to form anouter clover 4012 that is concentrically located with the inner clover4008 and has a diameter greater than the inner clover 4008. The innerapices 4010 of the inner clover 4008 can be coupled to the respectivecrowns 4006 near the center of the crowns 4006, while the outer members4004 can be coupled to sides of the respective crowns 4006. In thismanner, the inner and outer members 4002, 4004 can define gaps 4014therebetween extending along each aspect of the support frame 4000.

In the embodiment shown, the inner and outer members 4002, 4004 can begenerally parallel, with the inner members 4002 extending radiallyinward of the outer members 4004. In this manner, the gaps 4014 can beconfigured to receive the native leaflets 4016 of the aortic valve 4018(shown in phantom), with the inner members 4002 situated along theventricular surface of the leaflets 4016 and the outer members 4004situated along the aortic surface of the leaflets 4016 (when implantedin the native aortic valve). In some embodiments, the inner and outermembers 4002, 4004 can be shape set such that they are spring-biasedtoward one another. In this manner, the inner and outer members 4002,4004 can pinch and retain the native leaflets 4016 when the leaflets areinserted therebetween, thereby remodeling the aortic valve 4018 byreducing the valve circumference and/or the valvular orifice area. Theinner and outer members 4002, 4004 can be made from metal (e.g.,nitinol) or from suitable biocompatible polymers, and can be integrallyformed with the support frame 4000. Alternatively, the inner and outermembers 4002, 4004 can be separately formed and secured to the supportframe 4000 by, for example, welding, brazing, suture, adhesives, etc.

Referring to FIG. 128, the support frame 4000 can be configured to beloaded onto a delivery device 4020 in a radially collapsed state. Thedelivery device 4020 can be configured such that the inner clover 4008is held in a radially collapsed state by an inner sheath 4022, and theouter clover 4012 is held in a radially collapsed state by an outersheath 4024. When the delivery device 4020 is located in the aorta, theouter sheath 4024 can be partially retracted in the direction of arrow4026, thereby exposing the distal aspect of the outer clover 4012. Thispartial exposure of the outer clover 4012 can cause the outer members4004 to flare open to a diameter greater than the diameter of the aorticvalve. The outer members 4004 can be positioned in the nativepockets/sinuses behind the native leaflets. The inner sheath 4022 canthen be advanced in the direction of arrow 4028, exposing the innerclover 4008. Because the proximal aspect of the inner clover 4008 isstill constrained by the outer sheath 4024, the inner members 4002 canflare outward to a diameter greater than the diameter of the innerclover in its fully expanded configuration.

When the outer members 4004 of the outer clover 4012 are properlylocated behind the native leaflets (i.e., on the aortic side of theleaflets) and the inner members 4002 of the inner clover 4008 areproperly located on the ventricular side of the native leaflets, theouter sheath 4024 can be fully retracted. The inner and outer clovers4008, 4012 can then return to their respective natural diameters,engaging the native leaflets between the inner and outer clovers 4008,4012 and drawing the native leaflets together, thereby reducing thecircumference of the aortic valve and/or reducing the orifice area ofthe aortic valve.

In an alternative embodiment shown in FIG. 129, a proximal end portionof the inner sheath 4022 can include a balloon 4032 configured to flarethe outer members 4004 of the partially exposed outer clover 4012 wheninflated. Alternatively, the inner sheath 4022 can have a region ofincreased diameter configured to flare the outer members 4004 of theouter clover 4012 when the outer sheath 4024 is retracted.

FIG. 130 illustrates another embodiment of a support frame 4100comprising an annular main body configured as a clover 4104 formed by aplurality of angled struts 4102. The clover 4104 can have three apices4106 formed by the intersection of adjacent struts 4102. The supportframe 4100 can further include a leaflet-engaging mechanism in the formof clipping members 4108 coupled to each of the respective apices 4106.The clipping members 4108 can comprise retaining arms 4110, which canextend through sleeves 4111 coupled to the apices 4106 of the clover4104. The retaining arms 4110 can comprise coupling members configuredas claws 4122, which can engage a spherical end portion 4124 of anelongated member 4112 of a delivery device 4114, shown in FIG. 130. Inthis manner, the clipping members 4108 can be movable between a clampedposition and an unclamped position by action of the elongated members4112 of the delivery device 4114.

The clipping members 4108 can be located at the commissures 4118 of theaortic valve 4116 such that when the clipping members 4108 are movedfrom the unclamped to the clamped position, the native leaflets 4120 canbe pinched against the underlying struts 4102 of the clover 4104. Insome embodiments, the clover 4104 can be configured to have a diameterless than the natural diameter of the aortic valve 4116. In this manner,when the native leaflets 4120 are clipped against the clover 4104 by theclipping members 4108, the support frame 4100 can remodel the aorticvalve 4116 by drawing the native valve leaflets 4120 together. This canreduce the circumference of the aortic valve 4116 and reduce the area ofthe valve orifice, thereby reducing regurgitation.

The support frame 4100 can be loaded onto the delivery device 4114 withthe coupling members 4122 of the clipping members 4108 engaged withspherical end portions 4124 of the elongated members 4112. Initially,the clipping members 4108 can be located above the clover 4104 so as notto interfere with the placement of the clover 4104. The delivery device4124 can be advanced through a surgical opening in the left ventricleand into the aorta, where the clover 4104 can be positioned such thatthe apices 4106 are located between the leaflets 4120 at the commissures4118 of the aortic valve 4116. When the clover 4104 is properly located,the elongated members 4112 can be retracted, thereby moving the clippingmembers 4108 from the unclamped to the clamped position. This, in turn,can cause the leaflets 4120 to be pinched between the clipping members4108 and the struts 4102 of the clover 4104. The coupling members 4122can then be disengaged from the spherical end portions 4124 of theelongated members 4112, and the delivery device 4114 can be retracted.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the invention andshould not be taken as limiting the scope of the invention. Rather, thescope of the invention is defined by the following claims. We thereforeclaim as our invention all that comes within the scope and spirit ofthese claims.

What is claimed is:
 1. A method, comprising: implanting a support framein a native heart valve, the support frame comprising a main body formedby a plurality of inner members forming an inner clover and a pluralityof outer members forming an outer clover, gaps being located betweeninner members of the plurality of inner members and outer members of theplurality of outer members, the plurality of inner members and theplurality of outer members being coupled together, the inner cloverbeing radially inside the outer clover, and the outer clover having awidth larger than a width of the inner clover.
 2. The method of claim 1,wherein: implanting the support frame further comprises advancing thesupport frame through a patient's body in a radially collapsed state;and least partially advancing the support frame from a delivery sheathsuch that the support frame expands to an expanded state.
 3. The methodof claim 1, further comprising remodeling an annulus of the native heartvalve with the support frame.
 4. The method of claim 1, furthercomprising reducing a valvular orifice area of the native heart valvewith the support frame.
 5. The method of claim 1, further comprisingdeploying a prosthetic heart valve in the support frame.
 6. The methodof claim 1, wherein the support frame further comprises aleaflet-engaging mechanism configured to help secure the support frameat the native heart valve.
 7. The method of claim 6, wherein: theleaflet-engaging mechanism comprises an elongated member; and the methodfurther comprises moving the elongated member between two positions. 8.The method of claim 1, wherein the inner clover has three inner apicesformed by adjacent inner members.
 9. The method of claim 8, wherein theinner apices of the inner clover are coupled to respective crowns.
 10. Amethod, comprising: implanting a support frame in a native heart valve,the support frame comprising a main body formed by a plurality of curvedinner members forming an inner clover and a plurality of outer membersforming an outer clover, wherein the plurality of inner members and theplurality of outer members intersect with each other.
 11. The method ofclaim 10, wherein: implanting the support frame further comprisesadvancing the support frame through a patient's body in a radiallycollapsed state; and at least partially advancing the support frame froma delivery sheath such that the support frame expands to an expandedstate.
 12. The method of claim 10, further comprising remodeling anannulus of the native heart valve with the support frame.
 13. The methodof claim 10, further comprising reducing a valvular orifice area of thenative heart valve with the support frame.
 14. The method of claim 10,further comprising deploying a prosthetic heart valve in the supportframe.
 15. A method, comprising: implanting a support frame in a nativeheart valve, the support frame comprising a main body configured as aclover formed by a plurality of angled struts and a leaflet-engagingmechanism coupled to the main body and configured to secure the supportframe at the native heart valve.
 16. The support frame of claim 15,wherein the clover comprises three apices formed by the intersection ofadjacent struts of the plurality of angled struts.
 17. The method ofclaim 15, wherein: the leaflet-engaging mechanism comprises an elongatedmember; and the method further comprises moving the elongated memberbetween two positions.
 18. The method of claim 15, wherein: theleaflet-engaging mechanism comprises clipping members; and implantingthe support frame further comprises engaging leaflets of the nativeheart valve with the clipping arms.
 19. The method of claim 15, wherein:the leaflet-engaging mechanism comprises retaining arms; and implantingthe support frame further comprises moving the retaining arms betweentwo positions.
 20. The method of claim 19, further comprising moving theretaining arms through sleeves coupled to the main body.
 21. The methodof claim 15, wherein: implanting the support frame further comprisesadvancing the support frame through a patient's body in a radiallycollapsed state; and at least partially advancing the support frame froma delivery sheath such that the support frame expands to an expandedstate.
 22. The method of claim 15, further comprising reducing avalvular orifice area of the native heart valve with the support frame.23. The method of claim 15, further comprising deploying a prostheticheart valve in the support frame.
 24. The method of claim 15, wherein:the plurality of angled strut members are inner strut members; theclover is an inner clover; and the support frame further comprises aplurality of angled outer strut members forming an outer clover andcoupled to the inner strut members.